Quality Assurance Coordinator

Classification: Hourly/Non-Exempt
Reports to: QA Manager

PURPOSE

Ensure Plasma Center compliance with all Company’s Standard Operating Procedure Manual (the “SOPs”), current State and Federal guidelines, OSHA, CLIA, cGMP, and any other internal Company procedures

General Requirements—Adhere to all Standard Operating Procedures, Current Good Manufacturing Principles, and Company Policies.

ESSENTIAL RESPONSIBILITIES & DUTIES

• Authorized to STOP PRODUCTION
• Authorized to STOP RELEASE OF SHIPMENTS
• Authorized to institute new and revised procedures and forms when received from or requested by corporate.
• Assist in the ongoing development of the Q.A. program.
• Implement effective manufacturing process and systems controls.
• Perform all tracking and trend analysis requirements and provide the information to the Manager and corporate.
• Conduct monthly audits and discuss with the Quality Manager any compliance issues.
• Review donor records on a daily basis for accuracy (donor selection, acceptability, deferral, adverse reactions, and collection).
• Review plasma storage and distribution records as needed.
• Review of all donor reaction issues and complaints.
• Review of maintenance and cleaning records.
• Reviews issues and perform investigations.
• Review logs on a daily, weekly, monthly basis as required.
• Review/release of samples to laboratory.
• Review plasma packing.
• Ensure all plasma shipments meet specifications and requirements as defined in the SOP and/or the consignee specifications.
• Ensure accurate labeling and documentation of shipments.
• Authorize final shipment release.
• Ensure that CLIA proficiency test surveys, complaint investigations and training have been properly documented.
• Monitor and follow-up on corrective actions and preventative measures (CAPA).
• Assist in training of employees.
• Review of employee training records to ensure compliance with all applicable policies. Report any issues uncovered.
• Ensure that job and cGMP training is completed, documented and on file.
• Review & receive soft good and supply shipments.
• Assist Quality Manager in assuring performance of all validation protocols.
• Verify that calibration requirements for new equipment and those returned from service are performed prior to use.
• Verify that calibration, quality control, and maintenance is performed according to requirements.
• Release soft goods (verification of stock rotation).
• Be available and an integral part of all inspections.
• Assure that re-training of employees is effective and complete on all non-compliant issues.
• Make suggestions for changes in SOP as needed.
• Assist in resolving errors, issues, and non-compliance at a center.
• Assist the Quality Manager in evaluating all errors that occur during manufacturing (includes those identified before release of plasma).
• Supplies and reagents (manufacturer, lot number, expiration date, receipt date, disposition of rejected supplies and reagents).
• Ensure timely reports to CBER of errors/accidents that could affect the safety, purity, identity or quality of product.
• Report Emergency Situations immediately.
• Must be able to monitor and implement all quality initiatives and ensure strong regulatory compliance to all established policies/procedures at the center.
• Report monthly to Director of RA/QA
• Accept other assignments as delegated by Manager.
• Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.
• Any other duties as assigned.

REQUIREMENTS

• High School Diploma or Equivalent
• Current CPR card
• One year experience in a donor center with similar Quality Assurance or medical field experience or equivalent combination or education, training, and experience preferred
• Certified in Reception Area, Plasma Processing and Donor Collection Area (within six months of being assigned as Q.A. Coordinator).
• Successfully complete the required Q.A. training program.
• Organizational and communication skills required.
• Must have legible handwriting.
• Must be able to use a computer and have knowledge of mathematics.
• Be able to work independently and multi-task effectively.

PHYSICAL DEMANDS

Performing the responsibilities of the job requires ability to use hands and fingers to handle and feel objects, tools or controls; reach with hands and arms. Frequently required to stand, walk, climb and balance; and stoop, kneel, or crouch. Ability to read and review documents for up to eight (8) hours at a time and to stand for extended periods of time (2–4-hour intervals). Ability to read, type while sitting in front of a computer up to 2 hours at a time. Physical ability to operate plasmapheresis machine and related equipment. Manual dexterity to perform all phases of donor plasmapheresis that may require repetitive motions. Ability to lift, tug, and pull up to 50 pounds.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet to moderate. Occupational exposure to blood borne pathogens. Personal Protective Equipment required such as protective eyewear, garments and gloves. Work in a walk-in freezer for short intervals of time (-20C or colder).