What are the responsibilities and job description for the Quality Assurance Manager position at Kelly Science, Engineering, Technology & Telecom?
Senior Quality Assurance Manager (Part-Time)
Location: Solon, Ohio
Schedule: 24 hours per week (3 days/week onsite)
Salary: $75,000–$85,000 annually (part-time)
About the position:
Seeking an experienced Senior Quality Assurance Manager to lead and oversee the company's QMS and Quality Assurance operations. Reporting directly to the Head of Quality, this role is responsible for ensuring compliance with cGMP, regulatory requirements, and internal quality standards while supporting continuous improvement initiatives across the organization.
The ideal candidate is a hands-on quality professional with experience in pharmaceutical or biotechnology environments.
Key Responsibilities
- Lead the development, implementation, and continuous improvement of the company's QMS.
- Oversee creation, approval, distribution, control, and archival of cGMP documentation, including: SOPs, Technical reports, Batch records, Training records, Logbooks, Controlled quality documentation
- Manage document control processes, including document change requests, revision control, approval workflows, and employee training.
- Administer and maintain the company's training program, including: New employee onboarding, Annual GMP training, Refresher training; Job-specific training curricula, Training compliance records
- Review scientific documentation: Stability studies, Method validation reports, investigations
- Lead internal quality audits and support customer and regulatory inspections.
- Prepare audit reports, coordinate responses, and oversee CAPA.
- Investigate deviations, nonconformances, and OOS results and ensure timely resolution.
- Develop and monitor Quality Metrics to evaluate QMS performance and identify opportunities for improvement. Ensure compliance with FDA, ICH, and applicable cGMP regulations.
- Provide Quality Assurance oversight for laboratory and manufacturing activities.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Microbiology, Pharmaceutical Sciences, Biology, or a related scientific discipline.
- Minimum 5 years of Quality Assurance experience within the pharmaceutical, biotechnology, CDMO, or related regulated industry.
- Strong knowledge of cGMP regulations, FDA quality requirements, GDP, Pharmaceutical Quality Systems
- Experience with Document Control, CAPA, Change Control, Deviations, OOS investigations, Internal audits and Training management
- Strong technical writing and documentation skills.
- Proficiency with MS Office and eQMS.
Salary : $75,000 - $85,000