Quality Specialist

BioLife Solutions is repeatedly named one of Washington’s 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes generous company stock awards and a 401k matching program.

BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor® freeze media and HypoThermosol® shipping and storage media, ThawSTAR® family of automated, water-free thawing products, and  evo® cold chain management system. For more information, please visit: www.biolifesolutions.com

General Summary and Purpose:

The purpose of the Quality Specialist  role is to manage and oversee quality issues across the business, ensuring all programs are complying to standards and policies and are appropriate for use as the business grows. The Quality Specialist, by understanding critical to quality process elements, supports new product/equipment or system introduction, complaint management, process development activities, investigations, Corrective and Preventive Actions and process improvements as assigned, through robust validation and qualification design and execution.

Duties and Responsibilities:
10-75% of time allocation is on transactional activities

• Monitors and analyzes quality problems, in partnership with other business functions.
• Manages complaints, CAPAs, investigations and change management transactions.
• Develops corrective actions, solutions, and improvements in partnership with other functions.
• Determines quality improvement parameters by using relevant statistical methods
• Ensures documents progress through proper review and approvals.
• Fosters a positive relationship with BioLife suppliers. Manages supplier complaints (SCARs) with suppliers.
• Reviews and assesses supplier change notifications. Leads projects to assess notifications, as applicable.
• Effectively completes any assigned training in a timely manner.
• Performs statistical analysis for tracking, trending and reporting on Key Performance Indicators (KPIs). Develops new metrics when applicable.
  25-90% of time is on project related activities
• Manages and executes quality improvement activities as assigned.
• Owns implementation of quality improvements as assigned, in partnership with Quality Assurance and Operations.
• Develops and executes studies necessary to establish and sustain robust process improvements or in support of process development activities.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of the-art practices; participating in professional societies.
• Participates in internal, external, and third-party audits as required.
• Identifies, participates in, and leads improvement projects utilizing the concepts of Lean and Six Sigma. Monitors, achieves, and reports to project timelines.
• Perform other duties as assigned to support business needs

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

This is an exempt position that may require long hours or weekend work from time to time.
Reporting Relationships:

This position reports to the evo Operations Manager.

This position is on- site in Romeo, Michigan

Job Specifications:  

Education Minimum:

• Four-year degree in a scientific discipline required. Equivalent four years
  work experience may be acceptable in lieu of a degree.

Experience Requirement:

• 3+ years of experience working with in a quality engineering, quality
  assurance role or doing similar work. 2+ years in a GMP and/or ISO 13485 regulated manufacturing environment. Experience with basic statistical analysis required.

Field of expertise:

• Quality Engineering. Knowledge of ISO 13485, ISO 9001, 21 CFR 820, 21 CFR
  210/211, and EU GMP Annex 1. Six Sigma or Lean training preferred. Root cause investigation experience preferred.

• Experience or certifications in advanced data or statistical analysis preferred.

• This position requires a person who is highly organized and detail oriented and must meet performance expectations on schedule.

BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status. 

BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.

Our salary ranges are determined by position, level, location, and market competitive benchmarks.  Individual pay within a level is determined by work location (including geographic pay zone region), job related skills, experience, education, and training. 

The BioLife Solutions total rewards program includes, but is not limited to medical, dental, vision, 401K with generous match, life and disability insurance as well as time off programs of Vacation and Sick time.  Additionally, we believe in our team members sharing the success of our business and therefore we may provide cash bonus or stock equity grants based on company performance  as a part of our total rewards package.