What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Katalyst CRO?
Responsibilities
- Maintains an effective liaison and cooperative relationship with other client Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
- Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by client QA Operations.
- Ensures TPM procedures include but are not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
- Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
- Bachelor's degree preferably in Engineering or Science.
- Six years of experience within pharmaceutical operations, preferably Biologic manufacturing process.
- Knowledge of GMP regulations and standards affecting pharmaceutical products.
- Comprehensive knowledge and application of business and quality concepts.
- Strong analytical skills and attention to detail.
- Change plan, Exception Reports, SAP and LRMS experience is highly preferred.
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences.
- Strong interpersonal relations / communications skills.
- Ability to effectively communicate across all levels of the organization.
