Requisition ID 15204BR
Title Sr. QA Area Specialist
Job Category Quality
Job Description Position Purpose:
Ensures plant systems are compliant with applicable regulations. Oversees and coordinates daily process and activities of QA Specialists to assure objectives are met. Coordinate plant Quality training activities as well as departmental training for QA Specialist. Assist departments in corrective actions and quality improvement initiatives.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field or equivalent combination of education and experience.
Experience: 6+ years of QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
2+ years supervisory experience.
Demonstrated expertise in Regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
Preferred: Familiarity with local processes and quality systems
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, ISO standards and application of GMPs in aseptic manufacturing
Excellent written and verbal communication skills.
Basic computer skills in MS Office, MS Project, PowerPoint, etc.
Auditing experience with certification preferred
Mastery of Six Sigma and LEAN tools
Physical Requirements:
Normal work environment.Must be willing to work hours necessary to support a 24/7 operation. Also must be able to travel internationally on occasion.
Department QA Finished Production
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Sr. QA Area Specialist
Job Category Quality
Job Description Position Purpose:
Ensures plant systems are compliant with applicable regulations. Oversees and coordinates daily process and activities of QA Specialists to assure objectives are met. Coordinate plant Quality training activities as well as departmental training for QA Specialist. Assist departments in corrective actions and quality improvement initiatives.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field or equivalent combination of education and experience.
Experience: 6+ years of QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
2+ years supervisory experience.
Demonstrated expertise in Regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
Preferred: Familiarity with local processes and quality systems
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, ISO standards and application of GMPs in aseptic manufacturing
Excellent written and verbal communication skills.
Basic computer skills in MS Office, MS Project, PowerPoint, etc.
Auditing experience with certification preferred
Mastery of Six Sigma and LEAN tools
Physical Requirements:
Normal work environment.Must be willing to work hours necessary to support a 24/7 operation. Also must be able to travel internationally on occasion.
Department QA Finished Production
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%