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Open Positions:

QA/QC Coordinator

About Balassa Laboratories:

Balassa Laboratories has been a family-owned small business in the OTC pharmaceutical manufacturing industry since the 1960s. We are preparing to add cosmetics and medical devices to our product line. We are looking for a QA/QC employee to maintain the highest standards in our manufacturing processes and ensuring compliance with regulatory guidelines is paramount.

Position Overview:

The QA/QC Employee is responsible for maintaining oversight of cGMP processes to ensure the quality of our products. This role is crucial in monitoring quality assurance systems, overseeing manufacturing processes, and ensuring regulatory compliance.

Key Responsibilities:

  1. Monitor and oversee cGMP processes to ensure product quality.
  2. Provide oversight for processes and facilities, ensuring regulatory compliance in the manufacture of pharmaceutical, cosmetic, and medical device products.
  3. Conduct comprehensive reviews of batch and analytical data generated during manufacturing.
  4. Review cGMP test laboratories’ results relating to raw material, in-process, and product release.
  5. Monitor final batch disposition and participate in investigations and corrective action.
  6. Implement processes for deviations, change controls, and non-conformances.
  7. Assist in establishing process validation and implementation of IQ/OQ.
  8. Support cGMP programs by reviewing and approving site-specific batch records, procedures, protocols, and reports.
  9. Maintain oversight, review, and approval of deviation investigations and change controls.
  10. Draft and implement MBPRs, Process Validations, Equipment Qualification Master Plans (EQMP), and Cleaning Validations.
  11. Maintain safe quality products by following good manufacturing practices, allergen controls, and regulatory requirements.
  12. Document visitors on each visit in and out of the facility.
  13. Report all quality issues to management immediately.
  14. Train support staff in cGMP policies, procedures, and overall job function.
  15. Update and maintain SOPs in line with FDA CFR Part 211.
  16. Actively communicate with other departments to support cGMP programs.
  17. Represent the company during audits from regulatory bodies and clients.

Qualifications:

  1. Bachelor’s degree preferred.
  2. 2 years minimum QA/QC experience in an FDA regulated facility.
  3. 2 years of past leadership or managerial experience.*
  4. Strong working experience with GMP and FDA.
  5. Proficiency in Word, Excel, and QMS/ERP systems.
  6. Extensive knowledge of FDA CFR part 211; ability to interpret regulatory requirements.
  7. Capability to draft SOPs based on regulatory requirements.

*Can be combined with any other past experience.

What We Offer:

  1. Full-time employment.
  2. Benefits include paid time off.
  3. Regular work schedule: Monday to Friday.
  4. Work location: On-site.

Application Process: Interested candidates are invited to apply by submitting a resume and cover letter to Jim DiGaetano with the subject line “QA/QC Employee Application”.

Equal Opportunity Employer: Balassa Laboratories is an equal opportunity employer and is committed to creating a diverse and inclusive work environment.

Apply Now