Proclinical is currently recruiting for a Quality Assurance Specialist for a pharmaceutical company located in Philadelphia, PA. Successful candidate will thoroughly and accurately complete/assist in the preparation, review and approval of quality related documents and activities. This person works closely with personnel in all departments ensuring procedures are being followed and documentation requirements are being performed as required to ensure product quality and compliance to company procedures and regulatory requirements.
- Generation and review of Annual Product Reports.
- Responsible for QA review of investigations, root cause analysis, and Corrective and Preventivetion (CAPA) plans related to process / product deviations, material testing, and Out-of-Specification events.
- Generation and review of Change Control documents and impact assessments to ensure compliance with regulatory submission information.
- Support batch record review of new records, modified records, and executed records.
- Performs gap analysis of key quality indicators and analyze data to identify areas for improvement in the quality system.
- Generates and facilitates changes to SOPs, policies, training materials, and other documents for a technical discipline.
- Document internal audits and other quality assurance activities.
- Notify management of quality/compliance trends and service failures.
Skills and Requirements:
- A minimum of a BS in Quality Assurance or Regulatory Affairs, Chemistry or related science.
- 6-8 years' experience in pharmaceutical manufacturing with minimum 1-2 years' experience in quality assurance and/or compliance related fields.
- Proficient knowledge of a GMP production facility, manufacturing and packaging processes, and quality compliance.
- Computer literacy in Windows applications and the MS Office (Word, Excel, Outlook) package. Experience with Trackwise is beneficial
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Tooulas at (+1) 917-284-9670 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.