Quality Assurance Auditor (GMPGLP) Life SciencesPharmaBiotech
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Quality Assurance Auditor (GMP/GLP) - Life Sciences/Pharma/Biotech
Location: 466 Devon Park Dr Wayne PA 19087 (Onsite)
Duration: 1 Year
Pay Rate: $30.00/hr $33.00/hr. W2 All Inclusive
Interview: Onsite
Work Schedule: Monday Friday 9:00 AM 5:00 PM
Basic Summary
Perform audits of basic records reports and inspections of routine processes to assure compliance with applicable regulatory requirements international standards and corporate policies and procedures.
Essential Duties and Responsibilities
- Assure compliance with applicable federal state and local regulations and corporate policies.
- Perform data audits to ensure records are attributable legible contemporaneous original accurate (ALCOA) and compliant with SOPs protocols/batch records and corporate policies.
- Review SOPs protocols batch records and reports for accuracy completeness and compliance.
- Maintain written and signed records of all audits and inspections; participate in sponsor/client site visits and regulatory inspections.
- Participate in corrective and preventative actions (CAPA) to respond to client or regulatory findings.
- Identify document and report deviations from regulations SOPs and specifications.
- Conduct inspections/audits of subcontractors vendors and suppliers.
- Inspect materials and supplies for compliance with specifications.
- Assist in regulatory training and in scheduling/tracking QA audits and procedures.
- Participate in manufacturing line clearances and verify room acceptability prior to product manufacture.
- Perform Regulatory Affairs and Compliance project tasks as assigned.
Qualifications
- Education: Bachelors degree (B.A./B.S.) or equivalent preferably in a Life Science or related discipline.
- Experience: 1 2 years in a Quality Assurance (QA) or GMP/GLP role.
- Knowledge: Microsoft Office (Word Access Excel); FDA/GLP/GMP or ISO standards.
- Skills: Detail-oriented critical thinking analytical review verbal and written communication.
Physical Demands
- Regular use of computer systems and office machinery.
- Ability to move within office/lab environments and occasionally wear protective clothing/PPE.
Additional Details from Call Notes
- Hiring 2 employees for this role.
- Primary tasks include reviewing GMP documentation recorded during lab testing.
- Must have GMP laboratory experience; GLP experience can also be considered.
- Involves reviewing test reports copy editing and ensuring attention to detail.
- Entry-level (1 2 years) experience acceptable.
- Heavy training provided - initially 1 week plus ongoing training during work.
- Education: Bachelors degree in Biology or Science-related field required.
CANDIDATE SELF-ASSESSMENT QUALIFYING SKILL MATRIX
Please fill out the below matrix while applying. Use a scale of 1 (Beginner) to 10 (Expert) for the Self-Rating column.
| Skill / Qualification | Skill Rating (1 10) | Years of Experience | Additional Notes / Comments |
| Bachelors Degree in Life Sciences / Biology / Related Field |
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| Knowledge of GMP (Good Manufacturing Practices) |
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| Knowledge of GLP (Good Laboratory Practices) |
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| QA / Compliance / Documentation Auditing |
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| Reviewing SOPs Batch Records or Test Reports |
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| Data Integrity / ALCOA Principles |
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| CAPA (Corrective & Preventive Actions) Exposure |
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| Attention to Detail / Copy Editing |
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| Experience in Regulated Lab Environment |
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| Vendor / Supplier Audit Participation |
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| Microsoft Office (Word Excel Access) |
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| Communication & Reporting Skills |
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| Critical Thinking / Analytical Ability |
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| Ability to Work Onsite & Follow PPE Requirements |
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| Willingness to Learn (Heavy Training Environment) |
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Key Skills
- Laboratory Experience
- Quality Assurance
- FDA Regulations
- ISO 9001
- Quality Audits
- Quality Management
- GLP
- cGMP
- EPA
- QA/QC
- Toxicology Experience
- Aviation Experience
