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Quality Specialist - I (Assistant)

Talent Software Services, Inc.

West Point, PA

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JOB DETAILS
SALARY
$35–$40 Per Hour
SKILLS
Artificial Intelligence (AI), Biotech and Pharmaceutical, Communication Skills, Corporate Compliance, Cost Control, Detail Oriented, ERP (Enterprise Resource Planning), GMP (Good Manufacturing Practices), Lean Six Sigma, Microsoft Access Database, Microsoft Excel, Microsoft Outlook, Microsoft Product Family, Multitasking, Operational Communications, Organizational Skills, Performance Management, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Product Reviews, Product Support, Production Control, Production Systems, Productivity Management, Quality Control, Regulatory Compliance, Research Skills, SAP ECC (fka SAP R/3 and SAP ERP), Software Administration, Time Management, Writing Skills
LOCATION
West Point, PA
POSTED
5 days ago

Quality Specialist - I

" Hybrid Role @ WestPoint, PA(3 days onsite)
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.
Responsibilities:
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.

About the Company

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Talent Software Services, Inc.