The QA Manager will be responsible for monitoring and achieving department metrics and cycle times with adherence and compliance to cGMP/USP/ ISO and FDA guidance and requirements
Key Activities
Assure Test Method SIPs, SOPs, Material Specifications, etc. are up-to-date and manuals are current.
Monitor the effectiveness of training by ensuring the employees are adequately trained to perform their job duties.
Support document complaint investigations, evaluate and analyze trends of complaints.
Assist in the product return for complaint investigation, and replacement processes as needed.
Evaluate deviations/nonconformities and identify appropriate root cause(s) and assess quality impact.
Support CAPA process and follow-up to ensure CAPAs implemented are effective.
Support all remediation and continuous process improvement activities and plans.
Ensure that all data is organized and archived per appropriate workflows and SOPs.
Interpret and implement applicable standards, regulations and QMS documents effectively and accurately.
Establish, monitor, and improve critical KPIs in the QC lab related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing.
Provides support during internal and regulatory audits.
Gather, trend, and assess data and maintain metrics for Quality Assurance.
Perform prompt DHR review in compliance with FDA regulations and Good Documentation practices.
Write/update SOP's as needed about QMS and applicable regulations.
Other QA duties and projects as directed by the Director, QM
Preferred Skills
Extensive and strong analytical knowledge in performing investigations.
Good documentation and organization skills.
Educations & Experience
A minimum of Bachelor's degree in science
5-7 years of experience in a Quality Assurance role in GMP regulated Pharmaceutical/Medical Device/Consumer goods industry.
Prior experience working in electronic documentation systems preferred but not required
Are you looking for your next opportunity? We can help.
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application.