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Quality Rep

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BioLife Plasma Services

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Location:
United States , San Antonio

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

60800.00 - 83600.00 USD / Year
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Job Description:

Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.

Job Responsibility:

  • Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center
  • Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised
  • Stays current with federal, state, local and company-specific rules, regulations, and practices
  • Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety
  • Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation
  • Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements
  • Tracks deviations and trending in operating procedures and policies through established mechanisms
  • Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager
  • May stop operations or shipments when donor or product safety is or may be compromised
  • Identifies potential SOP revisions as needed to support continuous improvement
  • Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors
  • Assists center management teams to ensure timely closure of audit observations
  • Tracks responses to and evaluates effectiveness of corrective actions for errors
  • Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program
  • Coordinates management review meetings and participates in center staff meetings
  • Responsible for providing feedback and developing employees in the quality department
  • Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases
  • Fosters teamwork
  • Works collaboratively with staff, peers, and management to achieve business goals
  • Communicates continuously and resolves conflicts proactively
  • Provides timely feedback on performance and initiates disciplinary action when necessary
  • Participates in the evaluation and review of center staff
  • Ensures high levels of customer service and satisfaction
  • Meets and strives to exceed customer expectations
  • Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment
  • Production environment oversight

Requirements:

  • Minimum of one-year relevant work experience, or an equivalent combination of education and experience
  • Relevant work experience within medical or regulated field, highly desirable
  • Previous work experience within the plasma collection industry is strongly preferred
  • Computer skills in word processing, excel, data analysis and databases highly desirable
  • Demonstrated understanding of quality assurance in an FDA-regulated environment
  • Demonstrated understanding of plasma center operations
  • Effective organizational, technical and problem-solving skills
  • High School Diploma or equivalent required
  • Associates or Bachelor’s degree highly desirable

Nice to have:

  • Associates or Bachelor’s degree
  • Relevant work experience within medical or regulated field
  • Previous work experience within the plasma collection industry
  • Computer skills in word processing, excel, data analysis and databases
What we offer:
  • Medical, dental, vision insurance
  • 401(k) plan and company match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Tuition reimbursement program
  • Paid volunteer time off
  • Company holidays
  • Well-being benefits
  • Up to 80 hours of sick time per calendar year
  • Accrue up to 120 hours of paid vacation (new hires)

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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