QA Manager

Company: System One
Location: Durham
Posted on: November 22, 2021

Job Description:

Title:-- QA Manager-- Location:-- Durham, NC Duration:-- Direct Hire Schedule:-- M-F Full Time Target Start Date:-- ASAP Responsibilities:

• Capable of establishing and maintaining quality systems associated with product manufacturing conducted under GMP, including the production and testing of clinical supplies.
• Experience with creation, review and approval of standard operating procedures, test methods, batch records and other GMP documentation are required.
• Experience with MDI/Derma/Transdermal product manufacturing and testing is required.
• Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff
• Create and maintain Site Master Validation Plan Review of Batch Records and approve product disposition
• Review of analytical, stability test methods, protocols & reports Release of raw materials, components, in-process materials and finished products
• Review and approve investigation reports as applicable Assist in operational investigations to ensure timely completion Mentoring, coaching and training of department employees
• Facilitate vendor audits. Collaborate with other--affiliated sites to harmonize quality systems and leverage existing systems Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems
• Establishing and maintaining Site SOPs in collaboration with Mfg. staff
• Create and maintain Site Master Validation Plan Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports Requirements: PREFERRED:
  • Experience on deviation investigations for manufacturing and laboratory Ability to train personnel on GMP regulations and requirements Technical writing skill Familiarity with cGMP regulations, FDA guidance documents and QbD REQUIRED:
    • Bachelor's Degree in Chemistry
    • Minimum 10 years--- experience in Pharmaceutical Manufacturing QA position
    • Experience with MDI/Derma/Transdermal product manufacturing and testing is required.--
    • Experience with Collection, issuance, destruction, and inventories of all DEA Regulated Controlled Substance /List Chemicals located within WHS Controlled Substance Vault/Cages Must be able to review and write SOPs, review test methods, method validation protocols and reports as per FDA and ICH guidelines. --
    • Have ability to communicate effectively orally and in writing Have ability to motivate personnel to work together
    • Experience with analytical, stability protocols, reports, batch records, change control, investigations, deviations and other relevant GMP documentation
    • Possess organization skills
    • Possess analytical mind to deal with issues and offer solutions
    • Must be extremely reliable and committed Good oral and written communication skill and working in a team environment. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Durham , QA Manager, Executive , Durham, North Carolina