Pharma Quality Assurance Specialist (Onsite)

ACTalent; North Carolina; On-site; USD 58,000 - 76,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short & Long-term disability

Health Spending Account (HSA)

Transportation benefits

PTO / Vacation

Job summary

Actalent is seeking a Quality Assurance Specialist for a contract position in New Cumberland, PA. The role supports Operations and Quality to ensure regulatory compliance and drive continuous process improvements in a pharmaceutical or biotech setting.

You will partner with the Quality function to investigate quality events, maintain quality system documentation, contribute to CAPA, and assist in audits while applying cGMP principles daily.

Qualifications

• Bachelor's degree in Life Sciences or a technical field required.
• Experience with FDA regulations and regulatory compliance.
• Strong documentation, attention to detail, and accuracy.
• Familiarity with CAPA processes and documentation.
• Experience with document control within a regulated quality system.
• Familiarity with audits and deviation management in a regulated environment.

Responsibilities

• Support regulatory compliance and quality system standards.
• Investigate, document, and respond to quality events and deviations.
• Drive process improvements across operations and quality systems.
• Maintain and update quality system documentation for accuracy and regulatory alignment.
• Perform document control activities: create, revise, approve, archive documents.
• Contribute to CAPA activities and track effectiveness of actions.
• Support audits by preparing documentation and addressing observations.
• Apply cGMP principles to daily tasks and ensure adherence to practices.
• Review data to identify trends and propose quality improvements.
• Ensure quality records and documentation are complete and properly maintained.

Skills

QA experience in pharma/biotech

FDA regulations

cGMP knowledge

Documentation

CAPA processes

Document control

Audit processes

Deviation management

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Life Sciences or technical field

Tools

QMS software

Job description

Actalent is seeking a Quality Assurance Specialist for a contract position in New Cumberland, PA. The role supports Operations and Quality to ensure regulatory compliance and drive continuous process improvements in a pharmaceutical or biotech setting.

You will partner with the Quality function to investigate quality events, maintain quality system documentation, contribute to CAPA, and assist in audits while applying cGMP principles daily.