Jobs and Careers
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Sr Quality Assurance Supervisor
OctapharmaUnited Statesfull_timeVerifiedPosted 9 Jul 2024
About the role
How to Maximize
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Join an industry leader.
[Become one, too!]
There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a:
Sr. QUALITY ASSURANCE SUPERVISOR
This is What You’ll Do:
- Co-responsible with the Field Quality Manager for planning, developing, implementing, maintaining and evaluating the Quality training, Quality Systems and Quality Staff performance to ensure that policies and procedures are followed by all Donor Center staff members.
- Co-responsibility to lead and collaborate with the regional team during regularly scheduled regional meetings to discuss corporate initiatives, upcoming company events, donor centers issues, open deviations, training and personnel concerns.
- Determines if quality activities and manufacturing records are in compliance with SOPs (Standard Operating Procedures) and regulatory requirements; determines the need for corrective actions, ensures proper documentation, and determines effectiveness of the action.
- Advises other management team members and staff regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality, and resolution of same; develops and implements corrective actions.
- Performs final QA review and release for all product shipments and associated documents, to ensure shipment meets customer specifications.
- Performs regular quality compliance audits of the donor center activities, i.e. manufacturing records, donor processing, plasma collection, product sampling, processing, storage, and shipping.
- Conducts Donor Center site visits including attending regularly scheduled staff meetings with the Operations and Quality staff members. Provides feedback to the regional team regarding the visits including recommendations to improve overall center operations and quality best practices.
- Serves as a member of the interview and hiring team to evaluate and select Donor Center Operations, Quality, and Training leadership team members.
- Determines and prepares work schedules of Quality staff to ensure adequate donor center coverage.
- Provides direction and oversight of Quality staff, ensuring required quality tasks are completed within required timeframes.
- Identifies desired career path goals of Quality staff and provides coaching and mentoring to aid Quality staff in achievement of career goals.
- Writes and presents performance reviews to Quality staff. Delivers corrective/disciplinary action and termination when Quality staff performance is inadequate.
- Responsible for ensuring quality systems are implemented to ensure readiness for all internal and external audits within the region.
- Reviews, approves and ensures timely closure of major deviations and effective implementation and resolution of CAPAs.
- Monitors all CAPA’s to prevent recurrence and conducts performance checks to ensure effectiveness of CAPAs.
- Collaborates with the regional team to ensure that all parties are aligned with CAPA plans
This Is What It Takes:
- Ability to travel at a minimum of 30% of time, to include overnight travel and may include weekends.
- Bachelor's degree preferred. Job experience may be considered in lieu of a degree.
- Management/supervisory experience, highly preferred.
- Experience working in a highly regulated industry, preferred.
- Quality assurance focused work experience, preferred.
- Experience recruiting, hiring, training and managing the performance of employees, preferred.
- Strong communication, organizational, planning skills.
- Excellent written, verbal, and interpersonal communication skills.
- Demonstrated proficiency with Microsoft Office.
- Ability to work day and evening hours, weekends, holidays, and extended shifts.
Do Satisfying Work. Earn Real Rewards and Benefits.
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