ProClinical is advertising a vacancy for a QA Specialist position with a global biopharmaceutical company whose scientific research has resulted in 15 marketed products that benefit hundreds of thousands of patients. The organization is seeking an experienced applicant to join their team in California. This is an exciting opportunity to work with a company that prides itself on its unmatched patient access programs and bolster a career in the biopharmaceutical field.
- Performing a variety of activities to ensure compliance with applicable regulatory requirements.
- Maintaining programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Participating in reviewing of Standard Operating Procedures (SOPs) to ensure instructions are clear and consistent with quality objectives.
- Reviewing manufacturing, environmental monitoring, and quality control data for in-process and finished products with guidance from senior colleagues for investigation support.
- Working with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses, and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Conducting or serving as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
- Working with operating entities to develop solutions to more complex problems, identifying deviations from accepted practice, and evaluation impact assessment as required.
- Interfacing with contract manufacturers and suppliers to address documentation and compliance issues.
Skills and Requirements:
- A BS/BA degree and a minimum of 2-3 years of relevant experience.
- Educational background in the sciences (Engineering, Biology, and Chemistry).
- A thorough understanding and application of QA principles, concepts, industry practices, and standards.
- A thorough knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Sherron Howard at +267 435 8600 or upload your CV 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.
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