Endo Pharmaceuticals
Supervisor, Sterile Filling (Midnight Shift)
Endo Pharmaceuticals, Rochester, Michigan, United States, 48307
Supervisor, Sterile Filling
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. 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 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 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 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 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: 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
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. 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 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 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 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 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: 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