Position Summary
The Quality Assurance Manager oversees and manages the quality assurance process to adhere to guideline established by regulating agencies and boards to ensure compliance to regulations in the delivery of a quality product.
Duties and Responsibilities
Reviews/performs Daily Compliance Verification
Documents and reports results to the Director of Manufacturing
Environmental monitoring and documentation of personal monitoring, air bioburden, surface bioburden, temperatures, and particle counts
Collects environmental monitoring samples as necessary
Trains new Quality Assurance staff
Records sterility testing results, aseptic technique qualifications, and media fill process validations
Prepares/revises operating procedures and specifications
Reviews/approves routine change control requests as designated
Verifies that raw materials meet specifications
Oversees control of product labeling/label accountability
Recommends and/or implements improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments
Uses incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and responds to process and service issues
Leads root cause analysis and CAPA for audit observations, product complaints, product non-conformances, and in-process deviations
Directs the investigation of excursions in manufacturing or other related operations
Performs final review of test data/reports to ensure conformance to the established specifications and standard operating procedures
Verifies that product test results meet specifications
Tracks vendor equipment calibration and maintenance records and assess for deviations
Enters test results or summaries into the monthly and quarterly Quality Assurance report template
Documents results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions
Maintains quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification)
Knowledge and Skills
In-depth knowledge of USP , cGMP, FDA regulations (21 CFR Parts 210, 211), and ICH regulations
Effective communication skills, both written, and verbal
Leadership skills and the ability to facilitate the work activities of others
Proficiency with computer software, SharePoint preferred
Ability to act effectively as a member of a team to resolve problems
Good organizational and time management skills
Ability to work autonomously within established procedures and practices
Experience and Qualifications
Bachelor of Science in technical or scientific discipline preferably Microbiology and 10 years in pharmaceutical or medical device FDA GMP environment with 5+ years of supervisory experience
Experience with international regulatory agencies highly desirable
Thorough knowledge of pharmaceutical manufacturing/controls
Preferred ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional
Benefits
Health/Dental/Vision
Flexible Spending Account (FSA) or Health Savings Accounts (HSA)
401(k) with company matching
Paid Vacation (10 days)
Paid Holidays (8 days)