Quality Specialist

BIOLYPH is growing We are seeking an experienced, team-oriented, and responsive Quality Specialist. This full-time position offers your choice of a 4 or 5 day work week, competitive benefits, growth opportunities, and a culture of life-work balance. Our Quality Specialist will support specific areas of the Quality Management System (QMS) through auditing, documentation and record review, root cause analysis, and other quality functions. This will be done in alignment with BIOLYPH’s business model of producing our Clients’ IVD/RUO products Effectively, Efficiently, and Economically.

Essential Functions:

• Production Support and Monitoring:
  • Ensure processes in use are appropriately documented and controlled
  • Perform Batch Record Review
  • Perform review and disposition of equipment
• Corrective Action and Preventive Action:
  • Work cross-functionally to identify and resolve quality problems
  • Perform or assist in performing and documenting root cause and corrective action investigations, as necessary, to meet Client needs and to improve the QMS
  • Assist in identifying and implementing corrective and preventive actions
• Proactive Quality:
  • Identify, or assist in the identification/implementation of process and QMS improvements
• Audit System:
  • Participate in Internal Audits, as needed
  • Provide backroom support for External Audits, as needed
• Serve as an eQMS Administrator
• Facilitate Document Control functions
• As applicable, revise controlled procedures to facilitate QMS improvements
• Support the performance of BIOLYPH’s QMS, based on 21 CFR 820 and ISO 13485
• Work on projects assigned by Management

Qualifications:

• Bachelor’s Degree: Degree in Life Sciences or Chemistry preferred. Other degrees may be considered with applicable experience in a similar Quality Assurance role
• 2+ years of QA experience in a FDA regulated industry (preferred)
• Quality certification CPQA or CQIA (preferred)

Other Requirements:

• Working knowledge of 21 CFR 820 and ISO 13485 (preferred)
• Experience with Batch Record Review and controlled document review
• Audit experience
• Experience in performing Risk Assessments and Root Cause Analysis investigations (preferred)
• Well organized, pays attention to details
• Excellent computer skills (Outlook, Word, Excel, Access)
• Outstanding technical writing skills
• Capable of working independently and as a team
• Must be able to wear appropriate PPE
• Ability to sit for extended periods of time
• Normal vision acuity (with or without corrective lenses)
• Ability to identify and distinguish colors
• Ability to lift 10 lbs routinely/often/occasionally
• Ability to crouch, bend, twist and reach
• Ability to push/pull 25 lbs occasionally

About BIOLYPH:

Established in 1993, BIOLYPH is a dynamic, World-Class Contract Lyophilization and Component Packaging Service Company located in Chaska, Minnesota. Facilitated by the win-win relationships created with our Clients, we have continually experienced year-over-year growth. With the support of Management, BIOLYPH has maintained a workforce that is collaborative and innovative.

BIOLYPH Offers:

• Competitive pay commensurate with experience
• Benefits for full-time employees include:
  1. Health, Dental, Vision, Life, Short-term, and Long-term disability insurance
  2. Paid Time Off, Paid Holidays including Floating Holidays, Paid Birthdays
  3. 401k
  4. Employee Assistance Program
• Frequent company-sponsored events
• Clean, friendly, and collaborative work environment