Quality Assurance Coordinator

About the role

The Quality Assurance Coordinator will perform under the supervision of the Quality Assurance Manager and may also take instruction from the Center Manager and Director of Quality Assurance. The role ensures product integrity and donor health through compliance with FDA regulations, state regulations, company Standard Operating Procedure Manual guidelines, and other applicable standards.

Schedule: Monday - Friday, with every other Saturday (3 on and 4 off!). Includes 5 weeks of paid training (Monday - Friday).

Responsibilities

• Organize product in storage freezer, ensuring consistent and complete freezer organization.
• Perform QA review of product to be shipped to consignees.
• Set up, operate, and maintain instruments for manipulating, monitoring, and storing plasma products (Quality Control), supply management, and FIFO process release.
• Maintain instruments/equipment for processing, qualifying, and storing donor samples and products, including ensuring proper function and cleanliness.
• Document operational and maintenance activities as needed.
• Assist the Quality Assurance Manager in ensuring center operations, product storage, documentation, facility maintenance, quality control, and training comply with the company’s SOP, state/federal guidelines, OSHA, CLIA, cGMP, and internal procedures.
• Oversee and perform destruction of unsuitable units; quarantine and discard unacceptable samples and products.
• Oversee release and shipment of biohazardous waste.
• Perform internal audits and quality checks on-site.
• Assist with employee training and counseling as needed.
• Oversee receipt of center inventory, including donation supplies and QC reagents.
• Manage lot-controlled supplies, ensuring proper use, storage, and FIFO usage; approve and release new supply lots.
• Oversee daily management of samples to the testing lab; pack and ship samples.
• Assist in final QA review and release for all product shipments, ensuring compliance with customer specifications and product integrity.
• Assist in product shipment from the center; complete and review shipment paperwork.
• Report deviations or quality concerns to the Quality Manager.
• Assist with qualifying and reviewing equipment.
• Available to travel up to 25 miles to other facilities for training or staffing assistance.
• Perform other duties as assigned.

Requirements

• High School Diploma (required); Associate’s or Bachelor’s degree (preferred) in Management, Business, Nursing, Finance, or a science-related field.

Skills

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Consultation, ethical practice, and cultural awareness.
• Business acumen and relationship management.
• Strong computer skills; familiarity with Microsoft Office applications.

Physical Requirements

• Read computer screens, procedure manuals, and other documents.
• Hear doorbells, alarms, telephones, and other mechanical devices.
• Work confidently under observation during frequent quality inspections.
• Work in subzero walk-in freezer(s).
• Lift, pull, or tug up to 50 pounds to stock supplies or assist donors.
• Regularly use hands and fingers to handle objects, tools, and controls; reach with hands and arms.
• Vision abilities, including close vision.
• Stand for extended intervals; walk, climb, balance, stoop, kneel, and crouch.
• Operate equipment requiring repetitive motion and manual dexterity.
• Read while standing or sitting in front of a computer for extended periods (2-3 hours).
• Wear required personal protective equipment (PPE) such as eyewear, lab coats, and gloves.

Benefits

• Competitive wages.
• Flexible scheduling.
• Positive work environment.
• Paid training opportunities.
• Comprehensive medical and dental benefits.
• Paid Time Off.
• 401(K) retirement plan.