QA Specialist - Second Shift

Summary:

The QA Specialist demonstrates expertise in core areas of Quality Assurance.  They are responsible for supporting the established company’s Quality Systems to ensure activities supporting product development and commercialization are compliant with all applicable regulatory requirements and guidelines.

Essential Duties:

• On the Floor QA supports manufacturing activities including AQL visual inspection.
• Review and approve controlled cGMP Documents including procedures, protocols, reports, specifications, master batch records, and other related documents.
• Participates in the release of raw materials and/or finished products through review of test results, production records, and Certificate of Analysis.
• Review Quality Control Microdata and other related documents.
• Supports the development and maintenance of Quality Systems as appropriate.
• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
• Ensure targets are met for finished product and raw material release.
• Participates in the Quality Metrics Program, including trending of Quality Metric items. 
• Participates in Quality audit program to ensure compliance.
• Participates in Quality support of manufacturing activities.
• Initiate, Review, Approve, and/or Lead change controls.
• Perform Other Duties as assigned.

Knowledge, skills, and abilities:

• Knowledgeable in cGMP regulations and Industry Standards.
• Existing experience performing AQL visual inspection is a plus.
• Well-developed technical writing skills.
• Excellent skills in organization and planning. Detail oriented.
• Ability to build and maintain positive relationships with management and peers,
• Must be flexible, adaptable, and able to work independently and with cross-functional teams.
• Identify and drive continuous improvement ideas.
• Ability to assess problems, identify solutions, and implement necessary changes.
• Ability to be self-directed to perform work with little supervision.

Qualifications:

• Related BA/BS degree with a minimum of 4 years GMP experience and 3 years Quality Assurance experience.
• Experience in manufacturing aseptically filled, sterile products preferred.
• Qualified to work with controlled substances.