QA Clinical Supplies Specialist

Piper Companies; Lansdale (Montgomery County); On-site; USD 48,216 - 55,104; Full time

Benefits offered by this job

Comprehensive Benefits

401K

PTO

Sick Leave

Holidays

Job summary

An innovative pharmaceutical manufacturer in Lansdale, PA, is seeking a QA Clinical Supplies Specialist. This role involves electronic batch record reviews, ensuring compliance with regulations, and requires 5+ years of experience in quality assurance within biologics or vaccines. Candidates should have a quality mindset and familiarity with systems like SAP and Trackwise. Comprehensive benefits are offered, and applications open on 8/15/2025.

Qualifications

• 5+ years of relevant experience is strongly preferred.
• Quality mindset with background in GMP record review.
• Self-driven, and capable of working independently.

Responsibilities

• Electronic batch record review of finished clinical goods.
• Ensure clinical supplies are in compliance with cGMP and SOPs.
• Review of Electronic records for regulatory submissions.

Skills

Quality mindset

Self-driven

Experience in biologics

Experience with vaccines

Understanding of SAP

Understanding of Trackwise

Understanding of Midas

Understanding of Veeva

Understanding of QMAS

Education

Bachelor’s degree in related field

Job description

Piper Companiesis currently looking for an experiencedQA Clinical Supplies SpecialistinLansdale, PA to work for an innovative and growing pharmaceutical manufacturer.

Responsibilities for the QA Clinical Supplies Specialist:

·Electronic batch record review of finished clinical goods to ensure clinical supplies are incompliance with cGMP and SOPs

·Clinical supplier specifications, labeling, storage, etc.

·Review of Electronic records for regulatory submissions (IND or CTA)

·Areas of focus will include biologics, vaccines, combination products, etc.

Qualifications for the QA Clinical Supplies Specialist:

·5+ years of relevant experience is strongly preferred

·Quality mindset with background in GMP record review

·Self-driven, and capable of working independently

·Experience within biologics and/or vaccines

·Strong understanding of SAP, Trackwise, Midas, Veeva, and QMAS is preferred

·Bachelor’s degree in related field preferred

Compensation for the QA Clinical Supplies Specialist:

• Salary Range: $35 - $40/hr
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays

This job opens for applications on 8/15/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance

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