Plasma Quality Assurance Coordinator — Flexible Scheduling

B Positive Plasma LLC; Wilmington (DE); Hybrid; USD 55,000 - 85,000; 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 LLC is seeking a Quality Assurance Coordinator to assist the Quality Assurance Manager and Center Manager in maintaining product integrity and donor health by following FDA and state regulations and the Company SOPs. The role involves QA reviews, instrument setup and maintenance, and supporting audits and training.

Responsibilities include inventory oversight, lot-controlled supplies management, sample logistics to the testing lab, and ensuring proper documentation and shipment

Qualifications

• High School Diploma required; Associate's or Bachelor's degree preferred in Management, Business, Nursing, Finance, or science related field.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Familiarity with Microsoft Office applications.
• Ability to work within SOPs, regulations and quality systems.

Responsibilities

• 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
• 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 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

Skills

Verbal communication

Written communication

Interpersonal skills

Organizational skills

Ethical practice

Cultural awareness

Business acumen

Relationship management

Microsoft Office

Education

High School Diploma

Associate's or Bachelor's degree preferred

Tools

Microsoft Office

Job description

B Positive Plasma LLC is seeking a Quality Assurance Coordinator to assist the Quality Assurance Manager and Center Manager in maintaining product integrity and donor health by following FDA and state regulations and the Company SOPs. The role involves QA reviews, instrument setup and maintenance, and supporting audits and training.

Responsibilities include inventory oversight, lot-controlled supplies management, sample logistics to the testing lab, and ensuring proper documentation and shipment