Quality Specialist - I (Assistant)

• Primary duties may include but are not limited to the following:
• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.
• Coordinate and/or support the preparation of procedures, processes and quality improvements.
• Completing projects to improve the performance of our processes, including continuous process improvements, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.
• Assists in the coordination of significant quality events including fact finding, investigation support
• Actively using and championing the use of Lean Six Sigma and our company's Production System (MPS) tools, both in problem solving and day-to-day operational activities.

• Prefer quality experience(QA/QC) in batch record deposition.
• Operations in packaging clinical supplies.
• Previous SAP is nice to have.
• Veeva is nice to have.
• The work primarily involves reviewing clinical finished goods batch records, performing batch disposition, conducting label reviews, and supporting batch/product review activities.
• Preferred experience is in the pharmaceutical industry, especially in a GMP-regulated environment.
• Experience with systems such as ERP, SAP, MEDS, and VEEVA was mentioned as relevant or preferred.
• The ideal candidate should be confident, able to ask questions, communicate with operations partners, seek resolution on batch record issues, and be comfortable challenging processes or suggesting improvements.
• Manager emphasized interest in candidates who are proactive, outgoing, adaptable, and open to innovation, including AI-related process improvements.

Education:

• Bachelor's Degree or higher in engineering, science, or related discipline.

Required:

• Minimum 2 years of experience in the pharmaceutical or equivalent industry, Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.
• Familiarity with batch disposition activities
• Strong problem-solving, and written and oral communication skills
• Ability to manage multiple priorities
• Demonstrated teamwork skills and ability to work independently
• Proficiency in the use and maintenance of Microsoft applications (Excel, Outlook, and/or MS Access, Teams)
• Attention to detail, flexibility and an awareness of production and quality control problems.

Preferred:

• Proven ability to work independently and collaborate effectively as part of a team.
• Strong organizational, interactive, and time management skills.
• Computer skills; knowledge and competency in ERP, SAP, MEDS,VEEVA.

Note:

• Position available- 2
• Hybrid Role @ WestPoint, PA(3 days onsite)
• The roles will be hybrid, requiring three days on-site per week, with Tuesday and Wednesday mandatory on-site days and the third day typically flexible between Monday or Thursday. The assignment is expected to start around July 27 and will initially be for one year, with the possibility of extension up to two years.
• The positions are within MRL, working 8 hours per day / 40 hours per week, with no expected overtime and no travel requirement.
• The work primarily involves reviewing clinical finished goods batch records, performing batch disposition, conducting label reviews, and supporting batch/product review activities.
• Preferred experience is in the pharmaceutical industry, especially in a GMP-regulated environment. Experience with systems such as ERP, SAP, MEDS, and VEEVA was mentioned as relevant or preferred.
• The ideal candidate should be confident, able to ask questions, communicate with operations partners, seek resolution on batch record issues, and be comfortable challenging processes or suggesting improvements. Manager emphasized interest in candidates who are proactive, outgoing, adaptable, and open to innovation, including AI-related process improvements.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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