QA & Compliance Coordinator - Flexible Scheduling

B Positive Plasma - Cheltenham

Cheltenham (Montgomery County)

On-site

USD 50,000 - 75,000

Full time

6 days ago
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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 in Cheltenham is seeking a Quality Assurance Coordinator to support the QA Manager and help ensure product integrity under FDA and CLIA guidelines. The role focuses on QA reviews, equipment maintenance, and SOP compliance to safeguard donor health and product quality.

You will audit operations, manage inventory, train staff, and prepare documentation for shipments, while collaborating with center leadership to uphold regulatory standards and improve processes.

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
  • Consultation
  • Ethical Practice
  • Cultural Awareness
  • Business Acumen
  • Relationship Management
  • Strong computer skills; Familiarity with Microsoft Office applications

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)
  • Maintain instruments/equipment used for processing and/or qualifying and storage of donor samples and products
  • Document operational and maintenance activities when necessary
  • Assist QA Manager in ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training are current and consistent with SOPs
  • 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 QA Manager and Center Manager with employee training and counseling as needed
  • Oversee receipt of center inventory, including donation softgood supplies and QC reagents
  • Oversee management of lot-controlled supplies per SOP and ensure FIFO usage
  • Oversee daily management of samples to the testing lab; pack and ship samples
  • Assist in final QA review and release for all product shipments and documents
  • Assist in shipment of product from the center; complete shipment paperwork
  • Report deviations or quality concerns to QA Manager
  • Assist with qualifying and reviewing equipment
  • Travel up to 25 miles for training or staffing needs
  • Other duties as assigned

Job description

B Positive Plasma in Cheltenham is seeking a Quality Assurance Coordinator to support the QA Manager and help ensure product integrity under FDA and CLIA guidelines. The role focuses on QA reviews, equipment maintenance, and SOP compliance to safeguard donor health and product quality.

You will audit operations, manage inventory, train staff, and prepare documentation for shipments, while collaborating with center leadership to uphold regulatory standards and improve processes.

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