QAPS Area Specialist I 12 hr nights + every other weekend Job (clayton, NC, US)

Requisition ID 15689BR
Title QAPS Area Specialist I 12 hr nights + every other weekend
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
Department QA Production Support - Team C
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Shift Night