Quality Control Analyst, I

POSITION SUMMARY

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.

DUTIES AND RESPONSIBILITIES

Essential Functions:

• Perform microbiological assays for in-process and final product samples.
• Perform analytical methods for final bulk material/finished goods.
• Test and disposition of raw materials and perform environmental monitoring.
• Review of QC data for compliance to procedures and specifications.
• Calculate and evaluate results.
• Participate in lab maintenance and administration duties.
• Initiate lab investigations and deviations.
• Lab support including but not limited to glass washing, autoclaving, etc.
• Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
• Follow accurate oral and written procedures for testing of in-process and final product samples.
• Provide input to the technical composition of operating documentation.
• Work independently under general supervision and direction.
• Work in compliance with cGMPs.
• Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.
• Maintain lab documentation and notebooks, ensuring timely review, reconciliation and filing.
• Other duties as assigned

Leadership Responsibilities:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• Bachelor’s degree or equivalent education and experience. Biotechnology certification will also be considered.

Preferred Qualifications:

• 1 year of experience in a CGMP lab environment.
• Proficient in Outlook, MS Word, Excel and lab based data management systems.
• Experience with microbiological testing or environmental monitoring

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift 40 lbs.
• Requires working one day per weekend.
• Rotating holiday coverage
• Rotating off-shift remote alarm coverage
• May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.