Entry-Level Quality Assurance Associate
CDM
Summary
We are hiring a Quality Assurance Associate I to support our Head of Quality Assurance. This is an entry-level role. No industry experience is required, and we will train you in cGMP quality systems. You will review GMP records, manage controlled documents and support QA checks on the production floor, working closely with Manufacturing and Quality Control. In this role, accuracy and following procedures carefully matter more than prior experience.
Job description
Position Summary
We are hiring a Quality Assurance Associate I to support our Head of Quality Assurance. This is an entry-level role. No industry experience is required, and we will train you in cGMP quality systems. You will review GMP records, manage controlled documents and support QA checks on the production floor, working closely with Manufacturing and Quality Control. In this role, accuracy and following procedures carefully matter more than prior experience.
Key Responsibilities
- Review executed batch records, logbooks and forms for completeness, accuracy and compliance with cGMP and good documentation practices (GDP)
- Review calibration, preventive maintenance and cleaning records, and enter data into quality systems
- Issue, reconcile and archive controlled documents, including SOPs, forms, logbooks and batch records
- Track deviations, CAPAs and change controls, and follow up with owners until they are closed
- Keep training records and QA files ready for audit at all times
- Perform QA floor checks, line clearances and label reconciliation, including in classified cleanroom areas once gowning-qualified
- Compile and check batch documentation to support lot disposition
- Support customer audits, internal audits and FDA inspections
- Report documentation errors and quality issues promptly to the Head of Quality Assurance
- Perform other QA duties as assigned
Required Qualifications
- Bachelor's degree in biology, chemistry, biochemistry, microbiology or a related science field
- 0–2 years of experience; recent graduates are encouraged to apply
- Detail-oriented and organized, with accurate written work
- Clear written and verbal communication skills
- Working knowledge of Microsoft Word and Excel
Preferred Qualifications
- Laboratory research, coursework or an internship in a GMP, GLP or other regulated environment
- Familiarity with cGMP (21 CFR Parts 210 and 211), GDP and ALCOA+ data integrity principles
- Experience with an electronic document or quality management system
Schedule and Work Environment
- Full-time and on-site at our San Diego facility
- Monday–Friday day shift, with occasional extended hours to support production, audits or inspections
- Work in office and production areas, with part of the day spent standing and walking on the production floor
- Complete gowning qualification and follow gowning and hygiene requirements in classified cleanroom areas
Requirements
- Bachelor's degree in biology, chemistry, biochemistry, microbiology or a related science field
- 0–2 years of experience; recent graduates are encouraged to apply
- Detail-oriented and organized, with accurate written work
- Clear written and verbal communication skills
- Working knowledge of Microsoft Word and Excel
- Laboratory research, coursework or an internship in a GMP, GLP or other regulated environment (preferred)
- Familiarity with cGMP (21 CFR Parts 210 and 211), GDP and ALCOA+ data integrity principles (preferred)
- Experience with an electronic document or quality management system (preferred)
Benefits
- Overtime eligible
- Monday–Friday day shift
Company overview
CDM is a construction company operating in the construction industry sector. While specific details about the company's operations are limited based on available information, construction companies like CDM typically engage in various aspects of building and infrastructure development. Construction firms in this category generally undertake projects ranging from residential and commercial building construction to civil engineering works, infrastructure development, and specialized construction services. These companies play a vital role in urban development, economic growth, and community infrastructure improvement. Construction businesses typically manage project planning, design coordination, material procurement, construction execution, and quality control processes. They work with architects, engineers, subcontractors, and regulatory authorities to deliver completed projects that meet client specifications, building codes, and safety standards. The construction industry encompasses diverse specialties including general contracting, specialty trades, heavy construction, and construction management services.