Quality Assurance Coordinator

B Positive Plasma; Wilmington (DE); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive Wages

Flexible scheduling

Positive Work Environment

Paid training opportunities

Comprehensive Medical and Dental Benef

Paid Time Off

401(K)

Job summary

B Positive Plasma is seeking a Quality Assurance Coordinator to support the QA Manager and Center Manager in ensuring donor safety and product integrity under FDA and cGMP guidelines. The role emphasizes adherence to SOPs, regulatory standards, and continuous process improvement.

You will execute QA reviews, manage inspections, maintain QC instruments, train staff, perform internal audits, and assist in shipping documentation. Willingness to travel up to 25 miles is required.

Qualifications

• High School Diploma is required; an Associate's or Bachelor's degree is preferred in related fields.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Strong computer skills with familiarity in Microsoft Office.

Responsibilities

• Organize product in storage freezer with consistent organization.
• Perform the QA review of product to be shipped to the consignee.
• Set up, operate, and maintain instruments used for QC and storage in FIFO process.
• Maintain instruments/equipment used for processing, qualifying and storage of donor samples.
• Document operational activities and maintenance when necessary.
• Assist QA Manager and Center Manager with SOP compliance and audits.
• Oversee destruction of unsuitable units; quarantine and discard samples.
• Oversee release and shipment of biohazardous waste.
• Perform internal audits and quality checks on-site.
• Assist in staff training and counseling as needed.
• Oversee receipt of center inventory and QC reagents.
• Manage supply lots and ensure FIFO usage; QA approves new lots.
• Oversee daily management of samples to the testing lab; pack and ship samples.
• Assist with final QA review and release for shipments; ensure product integrity.
• Assist with shipment paperwork; travel up to 25 miles for training.
• Other duties as assigned.

Skills

Verbal and written communication

Interpersonal skills

Organizational skills

Consultation

Ethical practice

Cultural awareness

Business acumen

Relationship management

Education

High School Diploma

Associate's or Bachelor's degree preferred in Management, Business, Nursing, Finance, or science related field

Tools

Microsoft Office

Job description

Description

The Quality Assurance Coordinator will perform under the supervision of the Quality Assurance Manager, and at times will take instruction and tasks from the Center Manager and Director of Quality Assurance. The Quality Assurance Coordinator will ensure product integrity, and the continued good health of donors through the compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.

Job Type

Full-time

Description

The Quality Assurance Coordinator will perform under the supervision of the Quality Assurance Manager, and at times will take instruction and tasks from the Center Manager and Director of Quality Assurance. The Quality Assurance Coordinator will ensure product integrity, and the continued good health of donors through the compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.

Essential Duties and Responsibilities (the following list is intended to be a guideline. Other duties and responsibilities may be assigned):

• Organize product in storage freezer, ensuring freezer organization is complete and consistent
• Perform the QA review of product to be shipped to the consignee
• Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process
• Maintain instruments/equipment used for processing and/or qualifying and storage of donor samples and products. This includes ensuring the instruments/equipment is functioning/cleaned properly
• Document operational and maintenance activities when necessary
• Assists Quality Assurance Manager in ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training are current and consistent with the Company’s Standard Operating Procedures Manual (the “SOP”), current State and Federal guidelines, OSHA, CLIA, cGMP, and any other internal Company procedures
• Oversees and performs destruction of unsuitable units. Quarantine and discard unacceptable samples and products
• Oversees release and shipment of biohazardous waste
• Performs internal audits and quality checks on-site
• Assists Quality Assurance Manager and Center Manager with employee training and counseling as needed
• Oversees receipt of center inventory, including donation softgood supplies and QC reagents
• Oversees management of lot-controlled supplies, ensuring appropriate use and appropriate storage of supplies per SOP. Ensures supplies are used on a first in, first out basis. QA Approves and releases new supply lots as needed and ensures availability of supplies at the center
• Oversee the daily management of samples to the testing lab. Responsible to pack and ship samples to the testing lab
• Assists in the performance of final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications, and ensures the integrity and quality of the product shipped
• Assists in shipment of product from the center. Completes and reviews shipment paperwork required for each product shipment
• Reports to the Quality Manager any deviations or quality concerns observed at the center
• Assists with qualifying and reviewing equipment
• Available to travel up to 25 miles to other facility(ies) for training or assisting other center's staffing needs
• Other duties, as assigned

Education:

• High School Diploma, required; Associate's or Bachelor's degree, preferred in Management, Business, Nursing, Finance, or science related field

Skills And Qualifications

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Consultation.
• Ethical Practice.
• Cultural Awareness.
• Business Acumen.
• Relationship Management.
• Strong computer skills; Familiarity with Microsoft Office applications.

Physical Requirements

• Read computer screens, procedure manuals and other documents
• Hear doorbells, alarms, telephone, and other mechanical devices
• Work confidently while being observed during frequent quality inspections
• Work in walk in - Subzero freezer(s)
• Ability to lift, pull, tug up to 50 pounds to stock supplies and/or move or support donors
• Regularly required to use hands and fingers, to handle & feel objects, tools and controls; reach with hands and arms.
• Vision abilities required by this job, including close vision.
• Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch.
• Physical ability to operate equipment used that may require repetitive motion and manual dexterity.
• Ability to read while standing or sitting in front of a computer for extended periods of time (2-3 hours).
• Must wear personal protective equipment (PPE) required such as eyewear, lab coats, and gloves

B Positive Plasma Offers

• Competitive Wages
• Flexible scheduling
• Positive Work Environment
• Paid training opportunities
• Comprehensive Medical and Dental Benefits
• Paid Time Off
• 401(K)