Apply on Employer Site

BioLife Plasma Services · 2 days ago

Quality Rep

Worcester, MA

Full-time

Onsite

Entry Level

$74K/yr - $101K/yr

1+ years exp

BioLife Plasma Services is dedicated to improving the lives of patients with rare diseases. The Quality Rep role involves monitoring compliance with Good Manufacturing Practices and ensuring the safety of donors and products at the plasma center.

Health CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

Qualification

Quality AssuranceRegulatory ComplianceCGMP KnowledgeData AnalysisPlasma Center OperationsCoaching SkillsEffective CommunicationProblem-SolvingTeamwork

Required

Minimum of one-year relevant work experience, or an equivalent combination of education and experience

Demonstrated understanding of quality assurance in an FDA-regulated environment

Demonstrated understanding of plasma center operations

Effective organizational, technical and problem-solving skills

Attention to detail and ability to work independently

Effective coaching and counseling skills

High School Diploma or equivalent required

Preferred

Previous work experience within the plasma collection industry is strongly preferred

Associates or Bachelor's degree highly desirable

Computer skills in word processing, excel, data analysis and databases highly desirable

Benefits

Medical, dental, vision insurance

A 401(k) plan and company match

Short-term and long-term disability coverage

Basic life insurance

A tuition reimbursement program

Paid volunteer time off

Company holidays

Well-being benefits

Up to 80 hours of sick time

Up to 120 hours of paid vacation

Company

BioLife Plasma Services

Glassdoor3.3

Biolife Plasma Services is a healthcare Pharmaceutical firm that offers life-saving therapeutics that benefit thousands of people every day.

Founded in 1994

Mentor, Ohio, USA

5001-10000 employees

https://www.biolifeplasma.com/us/

H1B Sponsorship

BioLife Plasma Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2023 (2)

2022 (2)