Quality Assurance Specialist
Proclinical is seeking a Quality Assurance Specialist for a leading pharmaceutical company located in Pennsville, NJ.
Must be eligible to work in the US.
Job
Responsibilities:
Reviews and approves executed production records, production investigations, Master Production Records, COAs and DMFs Reviews lab sample results and manufacturing records relative to qualification/validation activities.
Conducts, writes, and reviews quality related investigations Responsible for cGMP compliance of assigned manufacturing operations / areas and conducts cGMP inspections Completes pre-campaign action items as assigned.
Responsible for the conditional / final release of materials Reviews finished product labels.
Prepares and reviews product trees Writes and reviews Product Validation / Qualification / Assessments documents, Equipment Qualifications / Assessments documents and Computerized Systems Validations / Assessments documents Reviews, evaluate and approves minor equipment changes Conducts environmental monitoring Skills and Requirements:
BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
BA/BS degree in microbiology is preferred Thorough knowledge of cGMP is required Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct Adheres to all applicable SHE and CGMP regulations Must have excellent communication skills Must be conscientious and detail-oriented Must have excellent computer skills (MS Office, WinLIMS, SAP) Must be a team player Must be able to self-manage daily work and set priorities Must be able to manage projects and prioritize appropriately If you are having difficulty in applying or if you have any questions, please contact Christina Chung at +(1) 857-233-9215 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-CC1INDCQA BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
BA/BS degree in microbiology is preferred o Thorough knowledge of cGMP is required o Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct o Adheres to all applicable SHE and CGMP regulations o Must have excellent communication skills o Must be conscientious and detail-oriented o Must have excellent computer skills (MS Office, WinLIMS, SAP) o Must be a team player o Must be able to self-manage daily work and set priorities o Must be able to manage projects and prioritize appropriately Recommended Skills Assessments Attention To Detail Auditing Biology Communication Conflict Management Estimated Salary: $20 to $28 per hour based on qualifications.
Must be eligible to work in the US.
Job
Responsibilities:
Reviews and approves executed production records, production investigations, Master Production Records, COAs and DMFs Reviews lab sample results and manufacturing records relative to qualification/validation activities.
Conducts, writes, and reviews quality related investigations Responsible for cGMP compliance of assigned manufacturing operations / areas and conducts cGMP inspections Completes pre-campaign action items as assigned.
Responsible for the conditional / final release of materials Reviews finished product labels.
Prepares and reviews product trees Writes and reviews Product Validation / Qualification / Assessments documents, Equipment Qualifications / Assessments documents and Computerized Systems Validations / Assessments documents Reviews, evaluate and approves minor equipment changes Conducts environmental monitoring Skills and Requirements:
BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
BA/BS degree in microbiology is preferred Thorough knowledge of cGMP is required Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct Adheres to all applicable SHE and CGMP regulations Must have excellent communication skills Must be conscientious and detail-oriented Must have excellent computer skills (MS Office, WinLIMS, SAP) Must be a team player Must be able to self-manage daily work and set priorities Must be able to manage projects and prioritize appropriately If you are having difficulty in applying or if you have any questions, please contact Christina Chung at +(1) 857-233-9215 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-CC1INDCQA BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
BA/BS degree in microbiology is preferred o Thorough knowledge of cGMP is required o Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct o Adheres to all applicable SHE and CGMP regulations o Must have excellent communication skills o Must be conscientious and detail-oriented o Must have excellent computer skills (MS Office, WinLIMS, SAP) o Must be a team player o Must be able to self-manage daily work and set priorities o Must be able to manage projects and prioritize appropriately Recommended Skills Assessments Attention To Detail Auditing Biology Communication Conflict Management Estimated Salary: $20 to $28 per hour based on qualifications.
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