Sr QA Specialist
Senior Quality Assurance Specialist
We are seeking a highly motivated individual to join us as a Senior Quality Assurance Specialist. Reporting to the Manager of Global Quality Assurance for Raw Materials and Reagents Center of Excellence, you will assist with managing the activities of the Quality Assurance department and supervise quality assurance efforts to ensure conformance to our quality standards and government regulations.
The Senior Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and our quality practices and be accountable for managing the QA projects and timelines. In addition, you will also support staff development for continual contributions towards our quality goals. This role is accountable for Quality Assurance responsibilities related to the disposition of raw materials globally.
* 7+ years of experience in a GMP environment with BS degree in the biological sciences or related field
* 5+ years of experience in a GMP environment with MS degree in the biological sciences or related field
* In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
* Proficient in cGMP regulations, quality systems and regulatory requirements.
* Experience writing, evaluating and closing investigations, CAPAs and change control records.
* Experience with conducting and managing internal and external audits.
* In-depth understanding and application of qualification and validation principles, concepts, practices, and standards.
* Ability to effectively negotiate and build collaboration amongst individuals.
* Demonstrated ability to develop, coach, and mentor key employees
* Proficient in MS Word, Excel, Power Point and other applications.
* Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Sthree US is acting as an Employment Business in relation to this vacancy.