Quality Assurance Coordinator Job

Quality Assurance Coordinator needed for a contract opportunity with Yoh's client located in King of Prussia, PA.

The Big Picture - Top Skills Should You Possess:

- Quality
- cGMP
- Regulatory

What You'll Be Doing:

- Collect and evaluate information to assist in internal and vendor audits, may support or conduct internal audits and prepare summary reports.
- Manage vendor lists.
- Review production and control records using established procedures and guidelines to support lot release of raw materials, components, and finished goods.
- Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods.
- Support special projects such as validation, site priority, or new products as required.
- Supports and / or assures completion of annual product reviews.
- Assist in data collection and preparation of trend analysis reports.
- Review for abnormal trends or indications of major problems.
- Advanced knowledge in cGMP, CFR and other regulations in order to assure quality compliance.
- Performs review of documents related to change management such as work order review.
- Assist in organizing and conducting training sessions.
- Assist junior staff with problem solving.
- Perform review of technical documents such as for equipment and process validation, automation and computer validation.
- Manages or supports closure quality system records including investigations, corrective and preventative actions, and change control.
- Update departmental documents such as SOPs as required.
- Attend meetings as a quality representative and provide input as required.

What You Need to Bring to the Table:

- BS or BA in Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related field.
- Sufficient technical depth or professional experience will be considered in lieu of technical degree.
- Minimum one (1) year industrial experience in quality organizations, either in operations or assurance functions.
- The position requires knowledge of cGMP in the regulated industry of pharmaceutical production and supply.

Bonus Points! Otherwise Known As Preferred Qualifications:

- Knowledge of NIH Guidelines, FDA, and other regulatory agency requirements

Opportunity is Calling, Apply Now!

Recruiter: Hannah Cihlar

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more !

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: PROF; CLINICAL

MONJOB

Ref: 1055281

SFSF: LS