Quality Assurance Auditor (GMPGLP) Life SciencesPharmaBiotech

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

Physical Demands

Additional Details from Call Notes

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

Knowledge of GMP (Good Manufacturing Practices)

Knowledge of GLP (Good Laboratory Practices)

QA / Compliance / Documentation Auditing

Reviewing SOPs Batch Records or Test Reports

Data Integrity / ALCOA Principles

CAPA (Corrective & Preventive Actions) Exposure

Attention to Detail / Copy Editing

Experience in Regulated Lab Environment

Vendor / Supplier Audit Participation

Microsoft Office (Word Excel Access)

Communication & Reporting Skills

Critical Thinking / Analytical Ability

Ability to Work Onsite & Follow PPE Requirements

Willingness to Learn (Heavy Training Environment)

Key Skills

Laboratory Experience,Quality Assurance,FDA Regulations,ISO 9001,Quality Audits,Quality Management,GLP,cGMP,EPA,QA / QC,Toxicology Experience,Aviation Experience

Employment Type : Full Time

Experience : years

Vacancy : 1