Quality Rep Jobs

Quality Rep

BioLife Plasma Services

Location:
United States , San Antonio

Category:
Quality Control

Contract Type:
Not provided

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

BioLife Plasma Services - All Job Offers

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Quality Rep

BioLife Plasma Services

Location:
United States , San Antonio

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 26, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

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