Quality Assurance Tech II

Job Description Summary

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

• Education:
  
  HS Diploma is required;
  Associates or Bachelor's degree is preferred.
• Experience:
  
  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 Track Wise experience preferred.

• 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

Reports to Quality Supervisor. Works with Manufacturing and Quality personnel on a daily basis.

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

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide 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.