Requisition ID 12385BR
Title QAPS Area Specialist I
Job Category Quality
Job Description Position Purpose:
Ensures timely review and approval of production records that are compliant with all applicable regulations. Works closely with manufacturing to improve quality of the product and production processes.
Education: Bachelor’s Degree in Life Sciences, Engineering, Computer Science, or related field or equivalent combination of education and experience
Experience: 3+ years of QA or manufacturing experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
Demonstrated experience leading in a matrixed environment and on cross-functional teams.
Technical/Process/Functional Knowledge:
Demonstrated knowledge of critical controls and input/output requirements for processes in the semi-finished manufacturing area, finished manufacturing areas or process utility area.
Demonstrated knowledge of US, EU regulations and guidelines, and application of GMP’s
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
Thorough knowledge of cGMPs OR extensive pharmaceutical manufacturing experience
Strong computer skills
Familiarity with Six Sigma and LEAN tools
Physical/ Other 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 or equivalent experience
Shift Night
Title QAPS Area Specialist I
Job Category Quality
Job Description Position Purpose:
Ensures timely review and approval of production records that are compliant with all applicable regulations. Works closely with manufacturing to improve quality of the product and production processes.
Education: Bachelor’s Degree in Life Sciences, Engineering, Computer Science, or related field or equivalent combination of education and experience
Experience: 3+ years of QA or manufacturing experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
Demonstrated experience leading in a matrixed environment and on cross-functional teams.
Technical/Process/Functional Knowledge:
Demonstrated knowledge of critical controls and input/output requirements for processes in the semi-finished manufacturing area, finished manufacturing areas or process utility area.
Demonstrated knowledge of US, EU regulations and guidelines, and application of GMP’s
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
Thorough knowledge of cGMPs OR extensive pharmaceutical manufacturing experience
Strong computer skills
Familiarity with Six Sigma and LEAN tools
Physical/ Other 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 or equivalent experience
Shift Night
