Quality Assurance Officers

Overview Location: West Point, PA (Hybrid - 3 days onsite/week)
Duration - 12 Months
Shift Time - Standard Shift
Job Description We are seeking a Quality Specialist I (Assistant) to support clinical supply quality operations within a GMP-regulated pharmaceutical environment. The role focuses on batch record review, batch disposition, label review, and quality support activities while ensuring compliance with company procedures and regulatory requirements.
Qualifications Must Have
Bachelor's degree in engineering, Life Sciences, or a related discipline.
Minimum 2 years of experience in the pharmaceutical industry or another GMP-regulated environment.
Hands-on experience with Batch Record Review and Batch Disposition .
Experience in Quality Assurance (QA), Quality Control (QC), Manufacturing Quality, or Operations .
Knowledge of clinical packaging operations or clinical supply manufacturing.
Strong understanding of GMP regulations and quality systems.
Excellent written and verbal communication skills.
Strong analytical and problem-solving abilities.
Ability to manage multiple priorities in a fast-paced environment.
Proficiency with Microsoft Excel, Outlook, and Teams .
Comfortable working cross-functionally with Operations and Quality teams.
Confident communicator who can identify issues, ask questions, and drive resolutions.
Detail-oriented, proactive, adaptable, and open to continuous process improvements.
Nice to Have Experience with SAP , ERP , MEDS , or Veeva .
Experience with Lean Six Sigma or continuous improvement initiatives.
Exposure to label review and clinical finished goods.
Experience supporting investigations and quality events.
Responsibilities Review clinical finished goods batch records for accuracy and GMP compliance.
Perform batch disposition activities in accordance with company procedures.
Conduct label reviews and support batch/product review activities.
Support quality investigations, fact-finding, and resolution of quality events.
Prepare and update SOPs, quality documents, and process improvements.
Participate in continuous improvement and Lean Six Sigma initiatives.
Collaborate with Manufacturing, Packaging, and Quality teams to resolve issues.
Ensure compliance with internal quality standards and regulatory requirements.
Work Schedule Hybrid role - 3 days onsite per week .
Tuesday and Wednesday are mandatory onsite .
Third onsite day is typically Monday or Thursday .
40 hours/week (8 hours/day) .
No expected overtime.
Must have QA/QC experience with Batch Record Review & Batch Disposition.
Experience in clinical packaging operations is highly preferred.

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