QA Material Compliance Assessor

Quality Seymour, Indiana


Description

Job Summary

Primarily responsible for review and disposition of active pharmaceutical ingredients, excipient ingredients, primary packaging components, and drug labeling along with their associated investigations, change control and master documents.  Responsible for final review of laboratory data generated for semi-finished and finished drug products.  Responsible for maintaining supporting systems such as Non-Conforming Materials, Quality/Regulatory Holds, and Material Certification.

Maintain a current knowledge of pharmaceutical cGMPs, current industry trends, and Guidance Documents issued by various international regulatory bodies (e.g., FDA, EMA, etc.).   

 

ESSENTIAL DUTIES / RESPONSIBILITIES:

  • Build and maintain a strong working relationship with all internal and external operational groups.
  • Support and / or assist in external and internal audits, and regulatory inspections.
  • Assure compliance with US, EU, Japanese, and Chinese cGMPs and other regulations as required
  • Responsible to work cooperatively with internal departments to address general compliance issues and provide input regarding proper documentation, handling, and quality impact.
  • Provide support in maintaining compliance with QA agreements with external customer/suppliers.
  • Responsible for maintaining the Non-Conforming Materials system.
  • Responsible for maintaining the Quality/Regulatory Hold system.
  • Responsible for maintaining the Material Certification process.
  • Responsible for maintaining the New Material Approval process.
  • Responsible for approval of change control and master CMC documentation for raw materials, primary packaging components and labeling
  • Responsible for review/disposition of executed material documentation for raw materials, primary packaging components and labeling
  • Responsible for investigation of any OOS, OOT, and deviations associated to raw materials, primary packaging components, or labeling; and assignment of any associated CAPAs.
  • Responsible for final review of laboratory data for drug products and generation of Certificates of Analysis to be used in consideration of batch disposition by the Product Compliance group.

Required Education:

          Bachelor’s Degree –  Scientific or related field
          Bachelor’s Degree – Chem, Biochem, Bio - Preferred

QUALIFICATIONS/EXPERIENCE:

  • At least 5 years of experience in the pharmaceutical or related industry with previous experience in a quality or laboratory area preferred. Demonstrated use and knowledge of cGMPs is required.  In lieu of a degree, additional relevant experience (7+ years) and/or specialized job skills would be required.

SPECIFIC SKILLS: label proofs

  • Must possess ability to prioritize, organize, and work effectively with minimal supervision. This includes strong follow-up skills, and the ability to provide timely closure of assigned tasks.
  • Strong attention to detail is mandatory as the primary responsibilities of this position are technical assessment of the completion, validity and compliance of laboratory data; and the compliance of labeling to the approved
  • Strong computer skills are required, with proficiency in the following applications essential: MS Word, MS Excel, and MS Access. Familiarity with SAP, Master Control, Sample Manager, and Chromeleon are beneficial.
  • Strong technical writing and problem solving skills. Experience in reviewing scientific documents / reports to assure compliance is a plus.
  • Good interpersonal skills with ability to achieve consensus and cooperation with varying departments and personalities are preferred. Strong communication skills (both oral and written) for internal and external contacts are required.
PHYSICAL REQUIREMENTS / ENVIRONMENT: 
  • LIGHT - Exert up to 20 lbs. of force occasionally, and / or up to 10 lbs. of force frequently, and / or a negligible amount of force constantly to move objects. Physical demands are in excess of those of sedentary work.  Light work usually requires walking or standing to a significant degree.
  • Work is performed primarily indoors in an office setting. The noise level in the work environment is low to moderate. Limited travel may be required.