Requisition ID 15599BR
Title QAPS Team Leader-12 hr nights + every other weekend
Job Category Quality
Job Description Position Purpose:
Supervises QA personnel assigned to a QAPS team. Ensures plant systems are compliant with applicable regulations. Works closely with manufacturing to improve quality of the product and production processes. Has product release authority.
Education: Bachelor’s Degree in Life Sciences, Engineering, Computer Science, or related field.
Experience: 7+ years of QA or manufacturing experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
2+ years supervisory experience.
Demonstrated expertise in quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
Technical/Process/Functional Knowledge:
Demonstrated knowledge of critical controls and input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing, and process utilities.
Expert knowledge of US, EU regulations and guidelines, and application of GMP’s in aseptic manufacturing
Excellent written and oral communication skills.
Basic computer skills in MS Office, MS Project, etc.
Ability to work day or evening shifts, as required
Preferred
Scientific or Engineering undergraduate degree
5-7 years experience in a leadership role in QA or pharmaceutical manufacturing
Strong computer skills
Mastery of Six Sigma and LEAN tools
Physical Requirements:
Ability to work 12 hour shifts or longer, day or night.
Ability to attain clean room gowning certification and work with hazardous materials including sanitants. (Aseptic Production)
Ability to work hours necessary to support shift production.
Ability to travel internationally
Ability to achieve core gown certification (Aseptic Production)
Department QA Production Support - Team D
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Shift Night
Title QAPS Team Leader-12 hr nights + every other weekend
Job Category Quality
Job Description Position Purpose:
Supervises QA personnel assigned to a QAPS team. Ensures plant systems are compliant with applicable regulations. Works closely with manufacturing to improve quality of the product and production processes. Has product release authority.
Education: Bachelor’s Degree in Life Sciences, Engineering, Computer Science, or related field.
Experience: 7+ years of QA or manufacturing experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
2+ years supervisory experience.
Demonstrated expertise in quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
Technical/Process/Functional Knowledge:
Demonstrated knowledge of critical controls and input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing, and process utilities.
Expert knowledge of US, EU regulations and guidelines, and application of GMP’s in aseptic manufacturing
Excellent written and oral communication skills.
Basic computer skills in MS Office, MS Project, etc.
Ability to work day or evening shifts, as required
Preferred
Scientific or Engineering undergraduate degree
5-7 years experience in a leadership role in QA or pharmaceutical manufacturing
Strong computer skills
Mastery of Six Sigma and LEAN tools
Physical Requirements:
Ability to work 12 hour shifts or longer, day or night.
Ability to attain clean room gowning certification and work with hazardous materials including sanitants. (Aseptic Production)
Ability to work hours necessary to support shift production.
Ability to travel internationally
Ability to achieve core gown certification (Aseptic Production)
Department QA Production Support - Team D
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Shift Night