KBI Biopharma Inc.
Supervisor, Manufacturing QA (Night Shift)
KBI Biopharma Inc., Durham, North Carolina, United States, 27703
Supervisor, Manufacturing QA (Night Shift) page is loaded## Supervisor, Manufacturing QA (Night Shift)locations:
USA - NC - Durham - National Waytime type:
Full timeposted on:
Posted 6 Days Agojob requisition id:
R00007992***Note: This is a night shift position.*****JOB SUMMARY:**The Manufacturing Quality Assurance (MQA) Supervisor is responsible for supervising the MQA team who supports the Manufacturing Process and Areas as part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to MQA team and Manufacturing with respect to process, SISPQ of product, and risk. The MQA Supervisor’s team shares responsibility for the inspection readiness of the site. MQA Supervisor routinely work on the cleanroom floor directly with the MQA and Manufacturing team to provide real time guidance and support. The Supervisor must adhere to procedures and policies to work on the Manufacturing floor. MQA Supervisor routinely collaborates with Manufacturing and work on team initiatives. The MQA Supervisor is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site.**JOB RESPONSIBILITIES:*** Time Supervise MQA team supporting Manufacturing. Provides training, coaching, and mentoring as needed.* Works directly with MQA team/Manufacturing to resolve deviations and other compliance issues in a timely manner.* Attend relevant operational meetings as MQA representative* Perform Change Control assessments for MQA* Performs client support relating to Batch Record reviews**MINIMUM REQUIREMENTS:*** Bachelor’s Degree or higher degree and appropriate years of experience (at least 6 years) in a Quality or Technical role in a GMP setting required.* 1-2 years of Supervisory experience preferred. Demonstrated ability to provide leadership to team.* Strong understanding of technical and compliance regulations for Clinical and Commercial Biopharmaceutical Programs.**Salary Range: $103,994 - $125,719**Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.Language Ability: Ability to read and comprehend instructions, correspondence, and memos. Ability to write routine correspondence. Ability to respond to common inquiries or complaints from employees and/or clients.Reasoning Ability: Ability to manage and prioritize multiple efforts independently. Ability to write, follow, issue, and explain clear instructions furnished in written and oral form. Ability to use risk to make decisions. Ability to methodically solve problems to their root causes.Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.Physical Demands: Ability to walk job sites, gown into cleanroom areas, lift small equipment and tools.Computer Skills: Microsoft Office Programs, E-mail, Electronic Document Management Systems, Electronic Batch Record Systems.Equipment Use Computers*KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.**I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.**I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.*At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.
Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to staffinginquiry@kbibiopharma.com. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position.
KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement. #J-18808-Ljbffr
USA - NC - Durham - National Waytime type:
Full timeposted on:
Posted 6 Days Agojob requisition id:
R00007992***Note: This is a night shift position.*****JOB SUMMARY:**The Manufacturing Quality Assurance (MQA) Supervisor is responsible for supervising the MQA team who supports the Manufacturing Process and Areas as part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to MQA team and Manufacturing with respect to process, SISPQ of product, and risk. The MQA Supervisor’s team shares responsibility for the inspection readiness of the site. MQA Supervisor routinely work on the cleanroom floor directly with the MQA and Manufacturing team to provide real time guidance and support. The Supervisor must adhere to procedures and policies to work on the Manufacturing floor. MQA Supervisor routinely collaborates with Manufacturing and work on team initiatives. The MQA Supervisor is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site.**JOB RESPONSIBILITIES:*** Time Supervise MQA team supporting Manufacturing. Provides training, coaching, and mentoring as needed.* Works directly with MQA team/Manufacturing to resolve deviations and other compliance issues in a timely manner.* Attend relevant operational meetings as MQA representative* Perform Change Control assessments for MQA* Performs client support relating to Batch Record reviews**MINIMUM REQUIREMENTS:*** Bachelor’s Degree or higher degree and appropriate years of experience (at least 6 years) in a Quality or Technical role in a GMP setting required.* 1-2 years of Supervisory experience preferred. Demonstrated ability to provide leadership to team.* Strong understanding of technical and compliance regulations for Clinical and Commercial Biopharmaceutical Programs.**Salary Range: $103,994 - $125,719**Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.Language Ability: Ability to read and comprehend instructions, correspondence, and memos. Ability to write routine correspondence. Ability to respond to common inquiries or complaints from employees and/or clients.Reasoning Ability: Ability to manage and prioritize multiple efforts independently. Ability to write, follow, issue, and explain clear instructions furnished in written and oral form. Ability to use risk to make decisions. Ability to methodically solve problems to their root causes.Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.Physical Demands: Ability to walk job sites, gown into cleanroom areas, lift small equipment and tools.Computer Skills: Microsoft Office Programs, E-mail, Electronic Document Management Systems, Electronic Batch Record Systems.Equipment Use Computers*KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.**I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.**I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.*At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.
Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to staffinginquiry@kbibiopharma.com. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position.
KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement. #J-18808-Ljbffr