Quality Review/Release I

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.