IDT Biologika Corporation (IDT) is recruiting for a unique and specific position - QA Specialist III/GMP Compliance - to function as a Certified Quality Auditor and to manage the IDT Supplier Qualification Program. He/she will identify and manage the continued rollout of GMP programs to support the manufacture of Phase 1 and Phase 2 Investigational Products (IPs), while ensuring compliance with FDA/EMA and other applicable GMP regulations and ISO 9001 guidelines.
Applies knowledge of pharmaceutical manufacturing technologies and FDA/EMA and other applicable GMP regulations for Active Pharmaceutical Ingredients and Phase 1 and Phase 2 Investigational Products.
Manages the IDT Supplier Qualification Program by scheduling initial and re-qualification activities, managing supplier quality surveys and certificates and performing evaluation of the supplier’s Quality Management System (QMS).
Manages the Supplier Quality Audit Program.
Establishes supplier quality agreements with approved suppliers. Manages changes associated with the qualification status of a supplier.
Facilitates the review and approval of supplier initiated changes and communicating the approved changes to the appropriate departments.
Assists in resolving supplier quality issues and performing investigations.
Provides support to the management of other QMS components, such as the Deviation Investigation Program, Internal Auditing Program, CAPA Program.
Reviews internal deviation investigations in eQMS for completeness, evaluates responses and provides investigation management support.
Hosts external client audits and provides support to QA Director during regulatory audits.
Develops SOPs pertinent to QA GMP Compliance activities.
Prepares trending and ad hoc reports from various QMS systems.
Bachelor’s in Science, Engineering or related field. Master’s highly desirable.
4+ years of experience in a GMP role within a Biologics/Vaccine GMP environment, preferably as a Certified Quality Auditor or Supplier Auditor.
ASQ CQA certification is mandatory. CQE certification is a plus.
Certified ISO auditor or equivalent.
Hands-on experience in Supplier Qualification and Supplier Audits is mandatory. Experience in some of the following areas is an advantage: eQMS management, NextDocs and/or Compliance Wire experience, Internal Audits, Investigation Management, Risk Assessment.
Strong investigation and root cause analysis skills
Good understanding of FDA & EU regulations (biologics or drugs), and USP, EP, and ICH standards and guidelines.
Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects/tasks
Ability to analyze data for accuracy and correctly interpret results.
Microsoft Office proficiency
IDT offers a competitive compensation package to include major medical/dental/vision, group life insurance, STD/LTD plans, 401K plan with company match, and paid vacation, sick and holidays. If interested in being part of a dynamic and growing company, please email your resume and cover letter including salary requirements to: firstname.lastname@example.org. Include the position for which you are applying in the subject line.
IDT Biologika Corporation is an Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status andwill not be discriminated against on the basis of disability.
IDT Biologika Corporation has a rich heritage of developing and manufacturing first-class pharmaceuticals, with a strong focus on immuno-biological products. The emphasis of our operations is on research and development,
production and sales for our own range of pharmaceuticals. Additionally, we provide technologies and services for the manufacture, bottling and packaging of parenteral products.