Quality Assurance Specialist

Xseer Pharma; Los Angeles (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Xseer Pharmaceuticals is seeking a QA Specialist to join the Quality Assurance Group. This role blends daily QA support with investigations, CAPA, change control, and batch disposition for sterile manufacturing. You will collaborate with Manufacturing, QC, Facilities, Supply Chain, and QA Management.

Qualifications include an Associate degree (Bachelor's preferred) and 2+ years of QA or cGMP experience. You will review records, support audits, train staff on QA procedures and quality systems.

Qualifications

• Associate degree required; bachelor's degree in a scientific or technical field preferred.
• 2+ years of QA or cGMP experience in pharmaceutical, biotechnology, or 503B operations.
• Strong knowledge of cGMP, good documentation practices (GDP), aseptic processes, deviations, CAPA, and change control.
• Experience reviewing batch records and using electronic document management or quality management systems.
• Ability to conduct investigations independently, maintain accurate documentation, and work across departments with minimal supervision.

Responsibilities

• Review executed batch records, logbooks, cleaning records, and component usage records; support batch disposition.
• Review and approve SOPs, controlled documents, test methods, forms, and labels within assigned authority.
• Initiate and investigate deviations, nonconformances, and out-of-specification or out-of-trend events; support or lead CAPA and effectiveness checks.
• Review change controls and support impact assessments and quality risk evaluations.
• Provide QA floor support for sterile compounding, filtration, filling, media fills, and packaging; perform walkthroughs and line clearance and label reviews.
• Review environmental monitoring records, QC data, trends, and facility and utility monitoring results.
• Support incoming material inspections, component release, vendor qualification, and supplier oversight.
• Support audits and inspections, prepare documentation, and train new employees on QA procedures, GDP, and quality systems.

Skills

cGMP knowledge

GDP knowledge

Aseptic processes

Deviations handling

CAPA

Change control

Education

Associate degree

Bachelor's degree in a scientific/technical field

Tools

Electronic document management

Quality management systems

Job description

Xseer Pharmaceuticals is hiring a QA Specialist for the Quality Assurance Group. This role combines daily QA support with independent work on investigations, CAPA, change control, and batch disposition. You will support sterile manufacturing and work with Manufacturing, QC, Facilities, Supply Chain, and QA Management.

Responsibilities

Review executed batch records, logbooks, cleaning records, and component usage records; support batch disposition.

Review and approve SOPs, controlled documents, test methods, forms, and labels within assigned authority.

Initiate and investigate deviations, nonconformances, and out-of-specification or out-of-trend events; support or lead CAPA and effectiveness checks.

Review change controls and support impact assessments and quality risk evaluations.

Provide QA floor support for sterile compounding, filtration, filling, media fills, and packaging; perform walkthroughs and line clearance and label reviews.

Review environmental monitoring records, QC data, trends, and facility and utility monitoring results.

Support incoming material inspections, component release, vendor qualification, and supplier oversight.

Support audits and inspections, prepare documentation, and train new employees on QA procedures, GDP, and quality systems.

Qualifications

Associate degree required; bachelor's degree in a scientific or technical field preferred.

2+ years of QA or cGMP experience in pharmaceutical, biotechnology, or 503B operations.

Strong knowledge of cGMP, good documentation practices (GDP), aseptic processes, deviations, CAPA, and change control.

Experience reviewing batch records and using electronic document management or quality management systems.

Ability to conduct investigations independently, maintain accurate documentation, and work across departments with minimal supervision.

Work environment

Facility and cleanroom work requires clean scrubs and appropriate PPE, extended sitting, standing, walking, computer use, and other physical activities. Duties include routine lifting up to 25 pounds, occasional lifting up to 50 pounds, and pushing or pulling carts or pallets with 100-200 pounds of force, unless a special provision applies. Physical duties may be performed with or without reasonable accommodation.