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QA Specialist
Actalent
An engineering and sciences services and talent solutions firm connecting specialized experts with industry projects.
23d ago
$28 - $32
Junior (1-3 years)
Full Time
San Diego, CA
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
What you would be doing
manage reports
supervise systems
regulatory affairs
quality systems
batch records
qc testing
Support engineering, maintenance, and production by reviewing PMs, calibration documents, function tests, and work orders.
Manage material review reports and control logbooks/notebooks.
Collaborate with regulatory affairs, project management, manufacturing, development, marketing, and corporate quality teams on customer projects, regulatory submissions, and harmonization of global quality standards.
Support quality systems, including supplier audits, change control, CAPA, complaint handling, document control systems, and employee cGMP training.
Release API batches after final QA Manager approval and review raw materials based on QC test results.
Participate in the annual analysis of quality system upgrades and adapt to new FDA or ICH regulatory changes.
Ensure adherence to quality system, cGMP, and ICH guidelines on site.
Conduct thorough batch record reviews and ensure document control activities are maintained.
Conduct annual product reviews and update Standard Operating Procedures (SOPs).
Collaborate regularly with OPS team leads to review batch records and resolve minor events.
Perform line clearance and create API labels.
What you bring
qa experience
problem solving
regulatory guidelines
detail orientation
bachelor’s degree
gmp compliance
2–4 years of experience in a QA role within a GMP-regulated pharmaceutical or biotech environment.
Problem-solving and deviation management skills.
Experience in peptide or oligonucleotide manufacturing is a plus.
Familiarity with FDA, ICH, and other global regulatory guidelines.
Strong attention to detail and organizational skills.
Proficiency in quality documentation and batch record review.
Effective written and verbal communication abilities.
Bachelor’s degree in a scientific or technical discipline such as Chemistry, Biology, or Pharmaceutical Sciences.
GMP compliance and regulatory knowledge.
Ability to manage cross-functional communication and collaboration.
Benefits
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
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