Quality AssociateÂ
Quality AssociateÂ
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
The Quality Associate plays a key role within the manufacturing team by ensuring inspection readiness maintaining site quality systems and driving compliance with cGMP standards and health authority requirements. This position supports manufacturing operations through proactive oversight of quality systems risk management and continuous improvement initiatives.
Responsibilities:
GMP Documentation & Validation:
- Review and approve GMP documentation including qualification and validation deliverables (e.g. change controls IQ/OQ/PQ protocols equipment validation computer systems logbooks and product quality evaluations).
- Ensure systems processes and equipment remain in a validated state and compliant with regulatory commitments.
Compliance Oversight:
- Monitor and maintain all aspects of GMP compliance across assigned areas.
- Interpret and apply emerging regulatory and GMP guidelines to site quality systems and programs.
- Prepare maintain and update site-level quality system policies and procedures.
- Maintain a regular presence on the production floor to oversee compliance and drive GMP culture.
Quality Systems Management:
- Review and approve deviations change controls investigations and product quality complaints.
- Assess deviations for impact on product quality and equipment qualification ensuring robust root cause analysis and effective CAPA implementation.
- Support and participate in Quality Risk Management activities (e.g. FMEAs).
- Escalate critical quality issues to management as appropriate.
Audits & Inspections:
- Participate in site self-inspection programs and audits to ensure compliance with quality system policies and regulatory standards.
- Support inspection readiness activities across all manufacturing operations.
Training & Communication:
- Educate and communicate GMP requirements policies and regulations to personnel.
- Promote a culture of compliance accuracy and continuous improvement within operations.
- Technical Knowledge & Development.
- Develop an in-depth understanding of site manufacturing processes facilities utilities and quality systems.
- Build knowledge of key operations including equipment procedures and personnel expertise.
Requirements:
- Bachelors degree (or equivalent) in a scientific or engineering discipline.
- Minimum 2 years of experience in pharmaceutical manufacturing within a Quality Assurance role.
- Strong knowledge of cGMP GDP data integrity and regulatory compliance.
- Experience with electronic Quality Management Systems such as TrackWise and/or Veeva.
- Demonstrated knowledge and application of ISPE C&Q and ASTM E2500 principles.
- Experience in API facility or unit operations (e.g. batch/continuous reactions filtration chromatography centrifugation drying utilities cleanrooms air handling systems).
- Previous exposure to MES systems (e.g. Syncade) Kneat and/or Val Genesis.
- ASQ Certification (or equivalent).
- Background in Computer System Quality Assurance (CSQA).
Employment Type
Full-time
