What are the responsibilities and job description for the Quality Assurance Manager position at W3Global?
Responsibilities
Job Description
Job Description
- Oversee Quality Assurance incoming inspection, line inspection, and label control personnel.
- Develop, maintain, and implement company procedures and policies in compliance with 21 CFR
- Perform internal quality audits.
- Perform external quality audits
- Perform Process Control Sheet (batch record) reviews.
- Author Standard Operating Procedures.
- Author Process Control Sheets (batch records).
- Manage the establishments CAPA program.
- Conduct investigations (Deviations, Non-Conformances, CAPA's, etc.) as necessary
- Supervise direct reports.
- Bachelor's degree in Chemistry, Biology, Microbiology, or related scientific discipline.
- Experience with implementing and maintaining ISO 13485 standards, preferred.
- Thorough understanding of cGMP's in the production of cosmetics, over-the-counter drugs,
- A minimum of 5 years quality assurance experience in a cGMP manufacturing facility.
- Minimum of 3 years of quality assurance supervisory experience. Experience in a medical
- Experience conducting vendor and/or customer audits
- Must be hands on and willing to fill in for direct reports as needed.
- Proficiency in Microsoft Office.
- Good written and verbal communication skills.
- Ability to work in a fast-paced environment.