Position Summary
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.
Responsibilities and Essential Duties
- 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.
Technical Skills Required
- 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.
Experience Required
- 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).
- Experience with batch documentation in a cGMP environment is a plus.
- Bilingual in English/Spanish a plus.
Physical Requirements
- Regularly sit, stand, and walk for extended periods of time.
- Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
- Physically able to lift 50 pounds repeatedly.
- Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
- Prolonged use of computer screen.
About Company
At the heart of what we are, we are a small company that specializes in manufacturing personal care products. While we are much bigger now than what we were 20 years ago or even 5 years ago, our company was built on a belief that being small meant that we had to be faster than our competition, smarter, braver and of course, nicer. We knew that in order to make it, we had to produce products that our customers needed, in time, priced right, and with the highest quality. We knew innovation meant pushing the envelope on design and thinking. Most importantly, we knew that developing relationships meant building a reputation for coming through on promises and standing behind our product. That is who we are today and how we operate every day.