Proclinical is currently seeking a QA Supervisor for a biopharmaceutical company located in Columbus, OH. Successful candidate will provide advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality.
- Determine if quality activities and manufacturing records follow SOPs and regulatory requirements; determine the need for corrective actions; ensure proper documentation and determine effectiveness of the action.
- Perform final QA review and release for all product shipments and associated documents to ensure shipments meet customer specifications.
- Perform regular quality compliance audits of the centre activities.
- Provide direction and oversight of Quality staff ensuring required quality tasks are completed within required time frames.
- Identify desired career path goals of the Quality staff and provide coaching and mentoring to aid the Quality staff in achievement of career goals.
- Prepare staff and co-host both internal and external audits.
- Collaborate with the Centre Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames.
- Ensure that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all centre staff.
- Obtain certification as a Quality Trainer; responsible for training of centre Quality Assurance staff.
- Analyse tracking and trending data; determine appropriate actions to improve trending.
Skills and Requirements:
- BA/BS in an applicable field of study (or an equivalent combination of education and experience may be considered). An ASQ certification is preferred.
- 1+ year of work experience in the biologics industry, preferably in a donor centre, and a 1+ year quality assurance-related work experience.
- Supervisory experience preferred.
- Must possess knowledge and aptitude to learn various computer software.
- Strong organizational skills, attention to detail and excellent interpersonal skills.
- Must have adequate communication skills and be able to effectively communicate with people at all levels.
- Must have ability to make decisions impacting the product and donor safety based on independent judgment and discretion.
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 Ysabel Capitan at (+1) 347-293-1123 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.