Compliance Specialist Job

Yoh has a contract opportunity for a COMPLIANCE SPECIALIST to join our client, a world leader in the pharmaceutical industry, located in MARIETTA, PA.

JOB RESPONSIBILITIES:

- Lead investigations, initiate deviations and determine corrective action.
- Leads cross functional team to investigate deviations.
- Prepares reports from outcome of investigations.
- Performs root cause analysis, FMEA's and collaborates.
- Reviews and assemble batch documentation testing results, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.
- Assess the impact of discrepancies on products or processes and recommend product disposition.
- Determines robust corrective actions and/or commitments.
- Ensures timely completion of manufacturing discrepancy commitments.
- Initiates manufacturing deviations using a qualified system such as SAP.
- Tracks, trends, and evaluates manufacturing discrepancies and work to determine root causes.
- Prepares and tracks change controls to make improvements outside of deviations.
- Maintains and tracks the CAPA's for the manufacturing department.
- Develops internal audit schedule (including area to be audited) on a yearly basis and communicates the schedule to the site Quality organization.
- Write clear concise summaries of investigations, product impact assessments, and commitments.

JOB QUALIFICATIONS:

- Must have deviation, CAPA, and investigation experience.
- B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy OR Degree in other discipline if sufficient technical depth has been achieved from professional experience.
- Minimum of three (3) years of pharmaceutical experience investigation manufacturing deviations either in a QA or manufacturing role; preferably in Biologics Secondary Manufacturing.
- Working knowledge of pharmaceutical facilities, equipment and systems.
- Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
- Lean and Six Sigma knowledge and User experience with SAP is highly preferred.
- Work experience with parenteral dosage forms (aseptically filled vials, syringes); Biologics is highly preferred.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Hannah Cihlar

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.

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

J2W: SCIENTIFIC; J2W: CLINICAL

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