Requisition ID 17371BR
Title Sr. QA Area Specialist - Line Filler 36
Job Category Quality
Job Description Position Purpose:
Perform compliance and Quality technical review/approvals of protocols/protocol data, specifications, deviations, configuration item lists, etc. Coordinates daily processes and Quality activities for the Line 36 project to ensure objectives are met. Verify systems developed for the L36 project are compliant with applicable regulations and company policies. Perform QA duties on the project and provide input to the project team on compliance. Coordinates with Quality Assurance Aseptic Production (QAAP) and other departments in corrective actions and quality improvement initiatives related to the L36 Project.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field.
Experience: 6+ 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. validation, Change Control, NC/CAPA, Audits, etc.)
Preferred:
Familiarity with local processes and quality systems
Technical/Process/Functional Knowledge:
Audit experience
Demonstrate knowledge of critical controls and input/output requirements for processes in these areas: semi-finished manufacturing and utilities, automation
Expert understanding of validation/system development life cycle approach. Expert in validation concepts with specific competency in Quality Compliance for computer validation
Expert in root cause analysis techniques and cGMP documentation practices. Expert understanding of change control processes.
Expert knowledge of US, EU regulations and guidelines, ISO standards and application of GMPs in aseptic manufacturing. Knowledge of compliance policies and procedures (such as Code of Federal Regulations/21 CFR Part 11).
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, cLEAN® 2 star or equivalent
Physical Requirements:
Normal office working environment.
Department Line Filler 36 Project
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%
Title Sr. QA Area Specialist - Line Filler 36
Job Category Quality
Job Description Position Purpose:
Perform compliance and Quality technical review/approvals of protocols/protocol data, specifications, deviations, configuration item lists, etc. Coordinates daily processes and Quality activities for the Line 36 project to ensure objectives are met. Verify systems developed for the L36 project are compliant with applicable regulations and company policies. Perform QA duties on the project and provide input to the project team on compliance. Coordinates with Quality Assurance Aseptic Production (QAAP) and other departments in corrective actions and quality improvement initiatives related to the L36 Project.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field.
Experience: 6+ 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. validation, Change Control, NC/CAPA, Audits, etc.)
Preferred:
Familiarity with local processes and quality systems
Technical/Process/Functional Knowledge:
Audit experience
Demonstrate knowledge of critical controls and input/output requirements for processes in these areas: semi-finished manufacturing and utilities, automation
Expert understanding of validation/system development life cycle approach. Expert in validation concepts with specific competency in Quality Compliance for computer validation
Expert in root cause analysis techniques and cGMP documentation practices. Expert understanding of change control processes.
Expert knowledge of US, EU regulations and guidelines, ISO standards and application of GMPs in aseptic manufacturing. Knowledge of compliance policies and procedures (such as Code of Federal Regulations/21 CFR Part 11).
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, cLEAN® 2 star or equivalent
Physical Requirements:
Normal office working environment.
Department Line Filler 36 Project
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%