Quality Assurance Specialist
Quality Assurance Specialist
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1 Vacancy
Job Description
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:
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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.
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CMO Governance:
- Oversee thirdparty supplier activities related to the manufacture packaging and testing of products.
- Maintain regular communication with CMOs and contract laboratories to ensure timely production and resolution of quality issues.
- Continuously monitor product performance and CMO activities.
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Quality Support and Deputation:
- Monitor coldchain transportation including qualification and routine processes.
- Provide input on Technical Quality Agreements and support product complaint resolution.
- Contribute to delegated projects and maintain CMO relationships.
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Stability Program:
- Review stability protocols and manage stability data.
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Audits:
- Lead the audit readiness program to ensure ongoing compliance.
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Quality/QMS Projects:
- Participate in quality and QMSrelated projects as required.
Qualifications:
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Education:
- Bachelors degree in a scientific discipline preferred.
- 57 years of experience working as a Quality Assurance Specialist.
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Experience:
- Direct experience with Quality Systems including deviations change controls complaints training supplier qualification and document management systems.
- Strong knowledge of cGMP requirements for sterile pharmaceutical manufacturing.
- Familiarity with GDP and ISO 13485 standards.
Competencies:
- Excellent interpersonal and communication skills both verbal and written.
- Ability to work effectively both independently and in a team environment.
- Strong attention to detail and organizational skills.
- Ability to manage multiple tasks with a high level of completion.
- Proven collaborator with a strong commitment to quality and continuous improvement.
Pharmaceutical Industry,Sterilization,Pharmaceutical Manufacturing,Medical Devices,Quality Assurance Professionals,Quality Assurance Review,Quality Assurance Processes
Employment Type
Full Time
