The purpose of this position is to act as the primary source of donor center quality expertise for Quality Supervisors and Quality Alternates. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
Manages assigned donor center readiness for FDA, EU, IQPP, OSHA, CLIA, COLA and customer inspections. Provides direction to Operations regarding adherence to procedural and regulatory requirements to ensure inspection readiness.
Manages corrective and preventive action (CAPA) teams to ensure issues are thoroughly evaluated including risk assessment, root cause analysis, and effectiveness checks.
Assists with the development of CAPA for internal and external audit observations.
Tracks CAPA commitments, effectiveness checks, take an active role in the development of preventive actions and monitors improvement initiatives.
Prepares, edits and revises SOPs and policies based on process improvements, regulatory inspections and/or changes.
Monitors adherence to SOP changes, and reports results to Director, Field Quality.
Develops and maintains strong working relationships with the donor centers.
Collaborates with Operations to drive continuous improvement initiatives identified through internal audits and industry best practices.
Participates in regularly scheduled staff meetings with Director, Field Quality, to discuss regulatory compliance issues, progress and status of audit responses, status of CAPA activities and department operations.
In conjunction with Operations and Senior Management, maintains the authority to stop center production.
Other job-related responsibilities as required.
Bachelor’s degree in life science or related field.
Five years’ experience in biologics, biotechnology or pharmaceutical industry with increasing quality responsibilities; or equivalent combination of education and experience.
Demonstrated knowledge of FDA and EU regulations and standards.
Strong written and verbal communication skills.
Plasma industry experience preferred.
Physical and Mental Working Conditions
Frequently required to travel overnight.
Frequently performs work while sitting.
Occasionally exposed to bloodborne pathogens and may be required to wear Personal Protective Equipment.
Required to communicate and interact with employees and donors.
2 openings. Telecommuting is allowed.
Additional Salary Information: This is a remote position.
For over 25 years, BPL has been a leader in the plasma industry. We are recognized both in the United States and in other countries for the consistently high quality of product we provide to pharmaceutical companies around the globe. BPL Plasma, Inc. is a subsidiary of Bio Products Laboratory Ltd, who manufactures a wide range of plasma products. Located in Elstree, near London (UK), we are commi...tted to research and development to maintain a key position in a constantly changing market in the 21st century.
BPL has 34 plasma centers throughout the United States. All of our plasma centers are FDA regulated and follow all industry guidelines. We pride ourselves on operating modern plasma facilities staffed with trained and friendly personnel.
In addition to collecting life-saving plasma, BPL compensates donors for their time, resulting in the infusion of thousands of dollars in to the local communities surrounding the centers. Moreover, BPL centers are involved in local area Chambers of Commerce and sponsor community activities such as neighborhood cleanups.