Quality Assurance Associate - Part time

About the Role

Reporting to the QA Supervisor, the QA Associate will work within an established culture of Quality Assurance and continuous improvement in all GMP areas. The role includes coaching and training operators and supervisors on proper documentation practices and cGMP requirements to ensure compliance during manufacturing.

Shift Availability: Day Shift, Monday - Friday, 8:00 AM - 4:30 PM.

Responsibilities

• Assess potential impact of incidents and processing deviations on the quality and suitability of the product for sale, including conducting batch record review and determining batch status (e.g., release, reject, or product hold).
• Conduct incoming inspection of printed roll-stock, labels, inserts, and cartons using statistical sampling plans to determine acceptability.
• Interact with label vendors to resolve problems.
• Investigate product complaints, deviations, and out-of-specification (OOS) results to determine product impact, root cause, and corrective/preventative actions.
• Perform internal quality audits compliant with corporate policies, practices, and procedures.
• Promote and advocate quality achievement and performance improvement across the organization.
• Ensure ongoing compliance with local, national, and international standards and legislation.
• Participate in HPRA, FDA, and customer audits/inspections, ensuring corrective actions are completed as required.
• Perform initial inspection of packaging lines to ensure compliance with company Standard Operating Procedures (SOP).
• Assist with resolution of compliance issues related to manufacturing lines to ensure adherence to SOPs.
• Write, review, and revise Standard Operating Procedures (SOP) and related forms for job-specific activities.
• Support the Continuous Improvement program throughout the company.
• Review batch documentation for cGMP compliance and work with production personnel to resolve discrepancies.
• Perform QA release of finished product, including counting and tagging outgoing pallets and establishing files for batch documentation.
• Prepare raw materials and finished product samples for submission to the Quality Control laboratory, monitor testing completion, and review analysis for conformity to specifications.
• Keep management informed of discrepancies, deviations, investigations, and unusual trends, assisting in identifying root causes and countermeasures.

Requirements

• Minimum 1+ years of direct work experience with pharmaceutical or food manufacturing Quality Assurance systems, regulations, guidelines, and associated standards.
• Training and knowledge of cGMP regulations.
• Bachelor’s degree in a related Science or equivalent experience.

Skills

• Extremely detail-oriented and analytical thinker with strong problem-solving ability.
• Able to develop, review, and maintain metrics and quality audits.
• Proficient in computer applications such as Microsoft Office, Excel, and PowerPoint.
• High integrity, excellent attention to detail, and ability to organize and prioritize.
• Highly motivated, self-directed, and capable of multi-tasking with minimal supervision.
• Strong work ethic and positive team attitude.
• Ability to interface directly with cross-functional teams.

Competencies

• Fostering Collaboration/Teamwork: Ability to work cooperatively with others, build partnerships, and respect diverse perspectives.
• Effective Communication: Ability to convey information clearly, listen actively, and facilitate information sharing.
• Execution/Accountability: Willingness to accept responsibility and experience consequences for performance.
• Analytical Thinking/Problem Solving: Ability to identify key components of problems, interpret information, and deduce cause and effect.
• Thoroughness/Detail-Oriented: Ensuring accuracy and completeness in work, preparing thoroughly for meetings, and following up on commitments.

Benefits

• Health Insurance (medical, dental, vision).
• 401(k) plan for retirement savings.
• Paid time off (vacation, sick leave, holidays).
• Life insurance.
• Employee assistance program.

About the Company

Bimeda is a leading global innovator, manufacturer, and marketer of veterinary pharmaceuticals and animal health products with over half a century of experience. The company operates eight state-of-the-art R&D centers and nine manufacturing facilities across seven countries, focusing on preventative, curative, and nutritional products. Bimeda is committed to fostering a diverse workforce and providing science-driven solutions to optimize animal health and productivity.