What are the responsibilities and job description for the Quality Assurance Specialist position at Stellar IT Solutions LLC?
Job Title : Quality Assurance Specialist (Sterile)
Job Location : Bridgewater, NJ (Remote)
Job Type : Remote (contract)
Job Description :
We are seeking a dedicated Quality Assurance Specialist to support the integration of newly acquired products into an established quality system. This role focuses on externally manufactured products within the pharmaceutical, biopharmaceutical, and medical device sectors. The successful candidate will ensure compliance with cGMP requirements and contribute to maintaining the highest quality standards.
Key Responsibilities :
Batch Review :
Review and approve documentation for Contract Manufacturing Organization (CMO) batch records.
- Address discrepancies in batch records and escalate issues as needed.
- Prepare disposition and release certifications for reviewed batch records.
CMO Governance :
Oversee third-party supplier activities related to the manufacture, packaging, and testing of products.
Quality Support and Deputation :
Monitor cold-chain transportation, including qualification and routine processes.
Stability Program :
Review stability protocols and manage stability data.
Audits :
Lead the audit readiness program to ensure ongoing compliance.
Quality / QMS Projects :
Participate in quality and QMS-related projects as required.
Qualifications : Education :
Bachelor's degree in a scientific discipline preferred.
Experience :
Direct experience with Quality Systems, including deviations, change controls, complaints, training, supplier qualification, and document management systems.
Competencies :
