Requisition ID 15739BR
Title QA Area Specialist II
Job Category Quality
Job Description Position Purpose:
Ensures Quality Control Laboratory, Finished Production, Information Technology (IT) and Quality systems are compliant with applicable regulations. Coordinates plant Quality training activities as well as participates in plant projects as a compliance advisor. Assists departments in corrective actions and quality improvement initiatives.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field
Experience: 4 years of QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
Demonstrated expertise in Regulations and quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
Demonstrated expertise in Quality Control Laboratory concepts (Microbiology and Chemistry) and demonstrated knowledge in Environmental Monitoring and Classification of Areas.
Preferred: Familiarity with local processes and quality systems
Technical/Process/Functional Knowledge:
Demonstrated knowledge of critical controls and input/output requirements for processes in Microbiology, Chemistry (QC Laboratory).
Knowledge of Finished Production processes (packaging and assembly).
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
Experience in the use of Six Sigma and LEAN tools
Physical Requirements:
Normal working environment. Must be able to work hours necessary to support a 24/7 operation. Also must be able to travel internationally.
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 QA Area Specialist II
Job Category Quality
Job Description Position Purpose:
Ensures Quality Control Laboratory, Finished Production, Information Technology (IT) and Quality systems are compliant with applicable regulations. Coordinates plant Quality training activities as well as participates in plant projects as a compliance advisor. Assists departments in corrective actions and quality improvement initiatives.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field
Experience: 4 years of QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
Demonstrated expertise in Regulations and quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
Demonstrated expertise in Quality Control Laboratory concepts (Microbiology and Chemistry) and demonstrated knowledge in Environmental Monitoring and Classification of Areas.
Preferred: Familiarity with local processes and quality systems
Technical/Process/Functional Knowledge:
Demonstrated knowledge of critical controls and input/output requirements for processes in Microbiology, Chemistry (QC Laboratory).
Knowledge of Finished Production processes (packaging and assembly).
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
Experience in the use of Six Sigma and LEAN tools
Physical Requirements:
Normal working environment. Must be able to work hours necessary to support a 24/7 operation. Also must be able to travel internationally.
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%