Quality Assurance Tech II

The Quality Assurance Technician II performs a variety of review processes with the intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is also responsible for return good inspections, cGMP area inspections and product inspections. This role ensures QA compliance and that cGMP principles are adhered to., * Execute batch record review and document deficiencies in a computerized system

• Identify exceptions and report exceptions to production
• Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
• Perform batch record accountability and Iron Mountain box reconciliation
• Execute line clearances and assist in inspection of returned goods
• Follow all internal and basic cGMP guidelines for pharmaceutical operations
• Perform GMP walkthroughs with production on a routine basis
• Participate in cross-functional teams to improve review efficiency and support
• Adhere to all safety rules and maintain 100% completion of all safety required training
• Maintain 100% on time Compliance Wire training, Reports to Quality Supervisor. Works with Manufacturing and Quality personnel on a daily basis

HS Diploma is required; Associates or Bachelor's degree is preferred., * Minimum of 1-3 years of document review experience in a cGMP environment preferred.

• Proficiency in MS Word and Excel.
• Proven knowledge of FDA and cGMP regulations preferred.
• LIMS, BPCS, and TrackWise experience preferred.

Preferred Skills/Qualifications:

• Ability to communicate at a high level of written and oral skills
• Ability to read and comprehend complex calculations and formulas
• Ability to focus and review batch records for an extended period of time
• Knowledge of cGMPs for APIs
• Ability to quickly identify, communicate and/or resolve issues
• Ability to read and understand complex batch records
• Ability to keep batch records organized and easily retrievable at all times
• Excellent verbal and written communication skills
• Ability to understand and apply good documentation practices
• Ability to build relationships with partners, Organizing, Peer Relationships, Functional/Technical Skill, Time Management, Priority Setting, Attention to Detail

• 85 % Office environment which includes sitting for long periods of time and computer use.
• 15 % Manufacturing environment exposure including temperature, noise, or chemical exposure.

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.