Quality Review/Release I
About The Position
The Quality Compliance Review/Release I position will be responsible for the day-to-day review of bulk and/or Finished Goods (FG) batch record documentation and release of bulk and FG to ensure they meet the high-quality standards set by management, customers, and regulatory requirements. They will work cross-functionally with Production and Manufacturing to ensure that specifications are being met. This position must be detail-oriented. The ideal candidate will demonstrate strong attention to detail, situational awareness, and the ability to ensure that the quality requirements are fulfilled, as required.
Requirements
- Detail oriented.
- Good verbal and written communication and computer literacy (MS Office) required.
- Good math proficiency.
- Organized and analytical.
- Must be able to work flexible schedules including overtime, nightshift, and weekend shifts.
- 2 or more years prior work experience in Consumer Packaged Goods (CPG), food, pharmaceutical, or manufacturing industry (can be substituted with education or applicable certifications).
Nice To Haves
- Experience with batch documentation in a cGMP environment is a plus.
- Bilingual in English/Spanish a plus.
Responsibilities
- Ensure SOPs are followed to meet and exceed quality standards set forth in specifications.
- Collaborate and communicate with upper management and Operations.
- Review batch documentation to ensure appropriate processes are being followed and documented.
- Release of batches in a highly-regulated environment.
- Review all documentation and have corrections made by the personnel who generated the documentation non-conformance.
- Enter Production KPI information, as appropriate.
- Ensure records are GMP-compliant as required by SOPs, methods, or regulations.
- Ensure GDP is followed on all applicable batch documentation.
- Support the company mission, values, and standards of ethics and integrity by incorporating these into the development and implementation of business plans.
- Participate in the generation of Annual Product Reviews (APRs) of OTC products.
- Own and lead special projects as assigned.
- Perform all other assigned duties as required by Quality Management.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
