Quality Assurance Technician - Part Time

Quality Assurance Technician

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 a global workforce, 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.

The Quality Assurance Technician performs a variety of review processes with the intent to identify and address record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role prepares and issues batch records and labels for use in the manufacturing process based on the production schedule. This role is also responsible for return good inspections, cGMP (current Good Manufacturing Practices) area inspections and product inspections and release.

This role is part of the site Quality team that ensures cGMP compliance at the site.

Essential Functions:

• 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
• 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
• Create, receive, print and issue labels and batch records to be used in the production of finished goods manufactured at the Greenville Plant.
• Verify accuracy and compliance of printed labeling prior to release to production. Execute finished product release and CoA issuance.

Minimum Requirements:

• HS Diploma is required;
  Associates or Bachelor's degree is preferred.

Experience:

• Minimum 1-3 years' experience in a role that requires attention to detail and accurate documentation. Proficiency in MS Word and Excel.
• Document review experience in a cGMP environment preferred.

Knowledge/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 GMPs 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

Competencies:

• Organizing, Peer Relationships, Functional/Technical Skill, Time Management, Priority Setting, Attention to Detail

Relationship with Others:

• Works with Manufacturing and Quality personnel on a daily basis

Working Conditions:

• 85 % Office environment which includes sitting for long periods of time and computer use
• 15 % Manufacturing environment exposure including temperature, noise, or chemical exposure.
• Must be able to lift 30 pounds and wear gowning (face mask, hair/beard net, safety glasses, safety shoes, gloves, and coveralls)

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.