Manager, Quality Job

MANAGER, QUALITY needed for a contract opportunity with Yoh's client located in Cambridge, MA.

WHAT YOU'LL BE DOING:

- Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to escalate and address unusually complex problems.
- Interfacings with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
- The lot review associate must maintain a high level of professionalism, efficiency, and follow-through in this critical role of commercial product lot release.
- Follow company policies and procedures.
- Prioritize workload to meet department and organizational targets and timelines.
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Perform any other tasks as requested by Management to support Quality oversight activities.
- Management of batch record review activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMP's and Client's policies and procedures, within standard lead times.
- Notification to Senior Management for all known delays in meeting established standard lead times or any potential quality issues.
- Interfacing with QA Lot Disposition Supervisors to ensure that final review activities are completed.
- Performing a review of investigations for potential cumulative effect to a batch history record.
- Performing a review of QC discrepancy reports, action limit excursions, assay variances, and anomalous results reports for potential correlation to the respective batch history record.

WHAT YOU NEED TO BRING TO THE TABLE:

- Three to five (3 - 5) years of pharmaceutical experience in manufacturing, quality assurance or quality control.
- At least one (1) year lot review or batch release experience in filling or biochemical operations.
- Must have excellent investigational and analytical skills with a proven ability to communicate effectively in both a written and verbal format.
- Ability to work both independently or collaboratively in a team structure.
- Have a proven ability to work well under pressure.
- Would prefer batch record review experience in Biotech industry.
- Fluency in German or French a plus.
- BA/BS in a relevant scientific/technical discipline with experience in biotech/pharmaceutical industry.
- The successful candidate will demonstrate effective problem solving, strong understanding of cGMP, excellent interpersonal skills, solid organizational skills and the ability to prioritize multiple tasks.
- Must be capable of applying cGMP concepts and requirements to evaluate product disposition using sound judgment and decision-making skills.
- Knowledge of cGMP's (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.
- Excellent communication skills, verbal, and written.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS/BA in life sciences

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a DayJ2W: CLINICAL; J2W: PROF

MONJOB J2WMIDATL

Ref:

SFSF: LS