Senior Quality Assurance Specialist -Contract - Cambridge, MA
Proclinical is seeking a dedicated and experienced Quality Assurance Specialist to join a dynamic team for a Senior position.
Primary Responsibilities:
In this role, the successful candidate will play a crucial part in overseeing the quality assurance process, ensuring that all products consistently meet both local and global quality standards.
Skills & Requirements:
- Bachelor's degree in a scientific discipline.
- Experience in a cGMP environment.
- Previous experience with quality systems overseeing cGMP production operations, including batch release, SAP and batch record review.
- Experience in regulatory inspection activities is desirable.
- Ability to manage multiple projects within tight timelines.
- Knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
- SAP knowledge is beneficial.
- Strong verbal and written communication skills.
- Ability to interact effectively with peers, subordinates, and senior personnel in a multidisciplinary environment.
- Root cause analysis experience is preferred.
- Experience with vaccines is an advantage.
The Senior Quality Assurance Specialist's responsibilities will be:
- Execute all activities in accordance with quality and regulatory standards and procedures.
- Foster a culture of quality excellence in all activities.
- Support continuous improvement and industrial excellence methodologies.
- Provide clear and proactive communication to customers to ensure timely resolution of issues.
- Support the batch release of drug substance, including documentation compilation as needed.
- Review manufacturing batch records for completeness and compliance with cGMPs.
- Provide on-the-floor support to Manufacturing.
- Perform SAP transactions related to batch record review.
- Maintain quality systems including Change Control, CAPAs, Deviations, and Self-inspection auditing.
- Support GMP compliance and inspection readiness within the organization.
- Assist in coordinating work for the QA Operations team to facilitate timely product lot release.
- Review calibration and work order activities.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
.png)
