Perform Quality Assurance (QA) activities to build, maintain, and improve the Company’s Quality Assurance Management Plan. Perform at an experienced and functional level therefore requiring limited supervision.
Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.
Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
Perform training and manage the Quality System’s Training Program.
Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
Make changes to SOPs, policies, training materials, and other documents in the records management system.
Assist during regulatory inspections.
Interface with various Divisions in problem resolution, and continual improvement.
Support manufacturing failure investigations, define investigational strategy.
Perform other duties as assigned.
Bachelors degree or equivalent experience.
Minimum 3 years experience in and Food and Drug Administration (FDA) regulated manufacturing environment.
Minimum 1 year experience training in a business setting.
Minimum 3 years of progressive experience in Quality Assurance
Project management experience.
Experience training safety, quality and GMPs.
Demonstrable strong written and verbal communication skills.
Excellent organizational skills.
Proven record of excellent documentation skills.
FDA & OSHA trained and familiar with current regulations.
Strong problem solving skills.
Project management and technical software skills in Microsoft Office Suites required.
Work well under pressure and able to prioritize workloads.
Ability to perform risk assessment.
Experience fostering teamwork to get results.
Well organized and multi-task oriented.
Ability to work independently on multiple projects.
Ability to read, write and speak English competently.
Worked in pharmaceutical or cosmetic manufacturing environment.
American Society for Quality certifications preferred.