Supervises a staff of QA Associates that are responsible for providing Quality Assurance support for IG and Albumin Purification processes which includes but is not limited to the following:
Providing Quality oversight and manufacturing support as required by Operations
Performing timely review of batch record documents on the shop floor
Identifying and assessing regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Shire quality practicesÂ
Quality supervisor will interact frequently with functional peer, and provide coaching, training and development to subordinates.
The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.Â
This position is for 3rd shift. Training may occur on day, swing, or night shift.
Essential Duties and Responsibilities:
Plans and schedules the work of QA Associates
Supports supervision for floor coverage and leads daily departmental operations
Provides training and coaching for the department
Identifies nonconformanceâs and participates in investigation and Corrective and Preventative Action (CAPA) activities
Provides training and coaching to local employees and others as neededÂ
Authors, review and/or approves written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet requirements
Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines Â
May be required to work weekends, evenings, off-hours, and extended periods of time
May be required to travel to local and international work locations for extended periods of time for training
Education and/or Experience
Bachelorâs degree in Engineering, Science or related field or equivalent. 3-5 years of experience required in the pharmaceutical or other similarly regulated industry preferred.
Must have the ability to encourage teamwork and drive decisions Strong communication/negotiation skills
Must have strong analytical and problem solving skills
Must have knowledge of FDA Regulations, and application of Good Manufacturing Practices
Experience with Trackwise, EBM, and Delta V/PLC is preferred Â
USA - GA - Social Circle - Hwy 278
Internal Number: R0028056
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.