Quality Assurance Auditor – Molecular BioA
Category: Regulatory / Compliance
Location: Greenfield, Indiana, USA
Job ID: 268020
Employment Type: Full-Time
Work Schedule: Monday – Friday, 8:00 AM – 5:00 PM
Job Summary
The Quality Assurance Auditor – Molecular BioA is responsible for ensuring compliance with GLP, GCP, and applicable regulatory requirements within Bioanalytical operations. The role involves conducting audits, inspections, quality reviews, training activities, and continuous improvement initiatives to maintain high-quality standards across Molecular Bioanalysis functions.
Key Responsibilities
Audit & Compliance Activities
Conduct inspections supporting GLP and GCP method validations, study data, and final reports.
Perform study-based, laboratory, process, and facility inspections.
Interpret and apply current regulations, policies, procedures, and industry guidance during audit activities.
Evaluate audit findings and follow up on corrective actions to ensure effective resolution.
Ensure ongoing compliance with GLP, GCP, and other applicable regulatory requirements.
Quality Assurance & Quality Systems
Review controlled document revisions and provide quality consultation.
Collaborate on quality metrics and identify compliance trends across departments.
Assist in the creation, revision, and improvement of QA Standard Operating Procedures (SOPs).
Participate in local and cross-site quality initiatives and continuous improvement programs.
Training & Process Improvement
Deliver training related to auditing practices and compliance requirements.
Support process improvement initiatives and recommend effective quality solutions.
Provide guidance and consultation to operational teams on quality-related matters.
Collaboration & Communication
Work closely with QA teams across multiple sites.
Communicate audit findings and compliance observations clearly and effectively.
Influence quality strategies and support organizational quality objectives.
Operational Responsibilities
Organize and manage workload to meet business timelines.
Perform additional duties and special projects as assigned by management.
Minimum Qualifications
Bachelor’s Degree in Life Sciences or equivalent Life Science experience.
3+ years of experience in a regulated environment (GLP/GCP roles).
1+ year of experience in Molecular Bioanalysis.
Uttar Pradesh :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Hilo | Honolulu |Tennessee :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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