What are the responsibilities and job description for the QA Compliance Consultant position at Zachary Piper LLC?
Piper Health & Sciences is actively seeking a QA Compliance Consultant to assist with transitioning and developing a mid-size biotechnology company from clinical stage to commercial readiness. This is a hybrid role based out of Rockville, MD.
Responsibilities for the QA Compliance Consultant include:
- Ensure inspection readiness by conducting and leading comprehensive internal audits and assessments to confirm QC laboratories, manufacturing suites, and supply chain areas are in compliance with cGMP and regulatory standards.
- Implement and improve data integrity practices and compliance with cGMP guidelines by providing oversight for routine Data Integrity auditing activities.
- Foster a culture of quality, continuous improvement, and accountability.
- Support supplier/vendor qualifications and audits to ensure compliance.
- Assist with producing and reporting on annual product quality reviews (APQR).
- Rectify any potential issues by effectively communicating with authorities, analyzing data and manufacturing processes, and implementing process improvements/corrective actions (CAPAs).
Qualifications for the QA Compliance Consultant include:
- 8 years of experience in GMP/cGMP quality compliance roles, preferably at a commercial-stage pharmaceutical or biotechnology organization.
- Proven expertise leading internal audits for inspection readiness.
- Experience performing supplier qualifications and/or annual quality product reviews is preferred.
- Minimum of a Bachelor’s degree in a related field is required.
Compensation for the QA Compliance Consultant includes:
- Salary Range: approximately $48.00 - $65.00 hourly, commensurate with experience
- Comprehensive Benefits: Cigna Medical, Dental, Vision Insurance, ADP 401k, STD, LTD, PTO, Paid Holidays, Sick leave as required by law
This job is open for applications beginning 2/5/2025. Applications for this role will be accepted at least 30 days from the posting date.
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Job Id:
137476
Job Category:
Life Sciences
Job Location:
Rockville, MD
Security Clearance:
None
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Cassandra Parisi
Salary : $48 - $65
