QA Assistant

5 days ago

West Chester, Pennsylvania, United States PharmaBlock Full time $40,000 - $70,000 per year

PharmaBlock (USA) Inc, with two R&D facilities in Great Philadelphia area (West Chester and Hatfield PA), is part of PharmaBlock Group, a fast growing and leading CDMO company that has been providing products and services to global pharmaceuticals companies since 2008. Over the past years, PharmaBlock has collaborated with over 80% of the top 20 pharmaceutical companies, and hundreds of small to medium-sized biotechs around the world. Our core values are equality, dedication, innovation, and fulfillment.

The QA Assistant will support the Quality Assurance function in maintaining GMP compliance . This position will have a strong emphasis on Master Control administration, training compliance, and document control. The role requires close collaboration across departments to ensure accurate, timely, and efficient quality and safety compliance.

Key Responsibilities

Master Control Administration

  • Manage user accounts, roles, and access levels within Master Control.
  • Configure workflows, templates, and system settings to align with QA and EHS requirements.
  • Provide first-line support for Master Control issues and coordinate with IT/vendor for troubleshooting.
  • Train staff on effective system use and promote continuous improvement of eQMS processes.

Training Compliance (GMP & EHS)

  • Administer, assign, and track employee training for GMP and EHS within Master Control.
  • Monitor training completion and generate compliance reports for management review.
  • Coordinate onboarding training for new hires and refresher sessions for existing staff.
  • Ensure training programs remain current and aligned with SOPs, regulatory standards, and EHS requirements.

Quality & Compliance Support

  • Maintain controlled documents (SOPs, protocols, specifications, reports) within Master Control.
  • Review executed batch records and logbooks for completeness and GMP compliance.
  • Support investigations, deviations, change controls, and CAPA management.

Audits & Regulatory Readiness

  • Support internal audits, client audits, and regulatory inspections.
  • Ensure training, document, and system records are complete, accurate, and audit-ready.
  • Assist in audit responses and corrective action follow-ups.

Qualifications

  • Education:
  • Bachelor's degree in STEM field (Chemistry, Pharmacy, Life Sciences, or related discipline) is preferred.
  • Experience:
  • 1–3 years of QA experience in a GMP-regulated pharmaceutical/CDMO environment.
  • Hands-on experience with Master Control preferred.
  • Familiarity with small molecule API development and manufacturing.
  • Skills & Competencies:
  • Strong organizational skills and attention to detail.
  • Ability to manage training and document systems for a multi-disciplinary workforce.
  • Effective cross-functional communication skills.
  • Proficiency in Microsoft Office Suite.

Job Type: Full-time

Job Types: Full-time, Contract

Pay: $45, $65,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee discount
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Referral program
  • Relocation assistance
  • Vision insurance

Ability to Commute:

  • West Chester, PA Required)

Ability to Relocate:

  • West Chester, PA 19380: Relocate before starting work (Required)

Work Location: In person

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