Endo International
Supervisor, Sterile Filling (Midnight Shift)
Endo International, Rochester, Michigan, us, 48308
Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and/or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
Job Description
Scope of Authority
-
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift
Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
Key Accountabilities
Operations
Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
Develops daily/weekly department work schedules, set priorities and verifies availability of resources
Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation
Ensure all equipment is working properly
Reviews batch records and supporting records prior to submission to Quality
Maintains a safe work environment
Completes in-process, set up checks and verification in alignment with Standard Operating Procedures
20%
Compliance
Understands and adheres to good documentation practices (GDP)
Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
Initiates and approves maximo work orders for equipment repairs or modifications
Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
Follow and comply with company Safety policies and OSHA Regulations
Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
25%
Supervisory
Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
Assigns manpower; initiates documentation of violations and disciplinary action with operators as required
Requests equipment and facility repairs, or modifications
Understands and complies with Union Agreement
Keeps manager informed of operations; elevates as needed
25%
Leadership
Reviews operational performance; drives improvement opportunities
Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication
Consistently communicate, follow and enforce SOP's and company policies and guidelines set forth in the employee handbook
Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve
Interfaces with suppliers of equipment or products and area consultants/experts
Conducts/supports CMO audits or regulatory agency inspections
30%
Total
100%
Qualifications
Education & Experience
Education
Required- B.A. /B.S. Degree in Science, Business or related field or significant experience
Desired- B.A. /B.S. Degree in Packaging, Science and/or Management degree
Experience
Required - None
Desired - 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent
Knowledge
Knowledge of Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge. Must be able to gain knowledge and expertise in aseptic processing
Skills
&
Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
For internal candidates: meets or exceeds expectations as follows:
Quality
- Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity
- Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security
- Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Attendance/Punctuality
- Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability
- Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Technical Skills
- Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Interpersonal Skills
- Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Written Communication
- Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.
Teamwork
- Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
Analytical
-
Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
Design
-
Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
Oral Communication
-
Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Professionalism
-
Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
Initiative
-
Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Resilience
-
Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
Problem Solving
-
Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Motivation
-
Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing
-
Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Adaptability
-
Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Physical & Work Requirements
Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
Stand, Walk, Sit, Talk and/or Hear
Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
Specific vision abilities required by this job include close vision
Frequently working near or exposed to moving mechanical parts
The noise level is moderate
Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
Work environment is a production/manufacturing plant
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and
qualifications.
Management reserves the right to change or modify such duties as required.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and/or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
Job Description
Scope of Authority
-
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift
Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
Key Accountabilities
Operations
Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
Develops daily/weekly department work schedules, set priorities and verifies availability of resources
Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation
Ensure all equipment is working properly
Reviews batch records and supporting records prior to submission to Quality
Maintains a safe work environment
Completes in-process, set up checks and verification in alignment with Standard Operating Procedures
20%
Compliance
Understands and adheres to good documentation practices (GDP)
Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
Initiates and approves maximo work orders for equipment repairs or modifications
Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
Follow and comply with company Safety policies and OSHA Regulations
Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
25%
Supervisory
Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
Assigns manpower; initiates documentation of violations and disciplinary action with operators as required
Requests equipment and facility repairs, or modifications
Understands and complies with Union Agreement
Keeps manager informed of operations; elevates as needed
25%
Leadership
Reviews operational performance; drives improvement opportunities
Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication
Consistently communicate, follow and enforce SOP's and company policies and guidelines set forth in the employee handbook
Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve
Interfaces with suppliers of equipment or products and area consultants/experts
Conducts/supports CMO audits or regulatory agency inspections
30%
Total
100%
Qualifications
Education & Experience
Education
Required- B.A. /B.S. Degree in Science, Business or related field or significant experience
Desired- B.A. /B.S. Degree in Packaging, Science and/or Management degree
Experience
Required - None
Desired - 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent
Knowledge
Knowledge of Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge. Must be able to gain knowledge and expertise in aseptic processing
Skills
&
Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
For internal candidates: meets or exceeds expectations as follows:
Quality
- Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity
- Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security
- Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Attendance/Punctuality
- Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability
- Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Technical Skills
- Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Interpersonal Skills
- Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Written Communication
- Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.
Teamwork
- Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
Analytical
-
Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
Design
-
Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
Oral Communication
-
Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Professionalism
-
Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
Initiative
-
Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Resilience
-
Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
Problem Solving
-
Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Motivation
-
Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing
-
Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Adaptability
-
Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Physical & Work Requirements
Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
Stand, Walk, Sit, Talk and/or Hear
Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
Specific vision abilities required by this job include close vision
Frequently working near or exposed to moving mechanical parts
The noise level is moderate
Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
Work environment is a production/manufacturing plant
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and
qualifications.
Management reserves the right to change or modify such duties as required.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.