Manufacturing Supervisor- Blood Components

Category
Experience Required
Yes
Degree Required
Yes
Employment Type
Employee
Work Schedule
Full-Time

Job Description
Job Description:

Manufacturing Supervisor- Blood Components

Responsible for the daily operations of Manufacturing. Hire and supervise staff. Participate in education and training activities. Ensure compliance with federal, state, ARCBS directives and regional policy and procedures and regulations. Ensure compliance with safety policies and procedures in the work area and use applicable protective equipment at all times to prevent exposure to potentially infectious blood and body fluids. Comply with the Clinical Laboratory I Improvement Amendments (CLIA). Perform all duties and responsibilities in compliance with standard operating procedures.

Responsibilities:

Responsible for the supervision of staff including, but not limited to, hiring, training, coaching, evaluating and disciplining to ensure a well-qualified team and to enhance operational success and compliance.
Responsible for staff training and certification of competency.
Prepare work schedules and ensure appropriate coverage for assigned shift.
Assist in the review and update of manufacturing procedures to comply with changes in regulations, ARCBS directives, local and regional policies and procedures and technical advancements.
Supervise all work processes and ensure work is performed accurately and efficiently.
Ensure compliance with state and federal regulations, AABB standards, ARCBS directives and regional policies and procedures.
Perform supervisory review of documents.
Supervise good inventory management practices.
Lead suspect product/sample management process.
Ensure products/samples are suitable for release for distribution and are managed appropriately.
Ensure monthly product QC requirements are met.
Ensure quality and quantity of manufacturing and distribution goals are met; including timelines.
Participate in documenting, investigating, troubleshooting and preventing recurrence of department errors and problems.
May participate in the validation of hardware, software, instrumentation, test kits, and procedures as directed.
May perform, review and approve quality control on products, reagents, equipment and various test kits. Maintain the required records and files.
Communicate with National Testing Laboratory staff when necessary to resolve problems, facilitate sample shipment, and clarify test data transmission issues.
Ensure accurate electronic and physical inventories location for products are maintained.
Perform other related duties as necessary.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required of staff so classified.
Qualifications

Bachelor's degree in science, or equivalent combination of related education and experience required. Three years experience including one year supervisory experience required.
MT (ASCP) certifications or equivalent certifications where required. Pharmaceutical manufacturing experience preferred.
Must have effective communication and customer service skills. Knowledge of blood products, supplies, and the ability to interact with diverse customers (internal and external) is required.