Quality Assurance Batch Record Reviewer Job

QUALITY ASSURANCE BATCH RECORD REVIEWER needed for a CONTRACT opportunity with Yoh's client located in San Carlos, CA

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- MUST BE ABLE TO WORK NIGHT SHIFT 10:00pm-6:30am
- 2-5 years related manufacturing or quality experience
- cGMP knowledge and experience
- Prior experience with Quality Assurance Batch Record Review and/or Person-In-Plant

WHAT YOU'LL BE DOING:

- Quality Assurance Batch Record Reviewer/Person-In-Plant to support Quality oversight of manufacturing operations for the NIGHT SHIFT.
- This is a temporary assignment.
- Responsible for on-the-floor, timely and effective GMP review and production close-out of batch record documentation in order to maintain a continuous flow of batch records
- Single point of contact in the plant during the assigned Manufacturing shift for the Batch Record Review Process and Quality matters.
- Operates on a 8-hour shift (10:00pm-6:30am) to support 24x5 Operations
- Responsibilities include approval and issuance of batch records, approving records; issue resolution; batch record review.
- Reviews batch documentation for accuracy and completeness according to cGMP's to ensure timely release.
- Conducts QA Person-In-Plant activities including, Area Approval, Line Clearance Approval, Batch Record Review, Deviation triage and preliminary investigation, etc.
- Assists with Deviation investigations, Compliance investigations, and Customer complaint investigations.
- Supports implementation of CAPAs, SOP revisions, Quality improvement initiatives, Operational Excellence projects, etc.
- Adheres to internal/external Guidelines, Specifications and Regulatory requirements while reviewing batch documentation.
- Ensures all GMP's, SOP's and protocols are followed.
- Positively interacts with internal associates to quickly and effectively resolve issues.
- Addresses deficiencies and ensures completion of follow-up actions, specifically those that target process fixes to maintain consistent resolutions to batch review issues according to GMP standards and objectives.

WHAT YOU NEED TO BRING TO THE TABLE:

- MUST BE ABLE TO WORK NIGHT SHIFT 10:00pm-6:30am. First couple weeks of training will be day shift.
- 2-5 years related manufacturing or quality experience. BS degree in science in preferred.
- Demonstrated cGMP knowledge and experience.
- Strong interpersonal, written, communication and problem solving skills.
- Must be well organized, flexible and able work with minimal supervision.
- Prior experience with Quality Assurance Batch Record Review and/or Person-In-Plant is preferred.
- Strong background and skills in Quality, Manufacturing, communication and computer related systems are preferred.
- Experience with Deviation Investigations and Root Cause Analysis is a plus.
- Experience with Microsoft Word/Excel, SAP and TrackWise is a plus.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS degree in science is preferred.

RECRUITER:Mary Nguyen

EMAIL:(see below)

Yoh, a DayJ2W: SCIENTIFIC

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