Quality Control Analyst II

Quality Control Analyst II

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Control professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to a Senior Manager, Quality Control at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

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:

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Perform maintenance on complex laboratory equipment.
• Participate in training of less experienced staff.
• Participate in transfer methods from support groups to the QC laboratory.
• May perform finished product review and lot release.
• Perform cell culture maintenance and assays
• Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance)
• Communicate inter-departmentally and with outside contacts to solve technical issues.
• Exercise sound judgment and decision making when problem solving.
• Revise standard operating procedures as needed.
• Perform deviation and lab investigations as needed.
• Master core responsibilities of an Analyst I.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

Leadership qualifications include, among other requirements:

• 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 a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• 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.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor's degree or equivalent and 2+ years of experience in a lab setting.
• 2+ years of experience with primary cells and cell culture
• 1 year of experience in flow cytometry and/or molecular biology

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, biological assays, or environmental monitoring.
• Experience in a biotech, pharmaceutical or other regulated industry.
• Excellent communication skills, verbal and non-verbal desired.
• Excellent technical writing and investigational skills.
• Experience with PCR based methodology or cell culture methods.
• Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift 40 lbs.
• Requires working both weekend days.
• Rotating holiday coverage.
• Rotating off-shift alarm coverage. Must carry a company issued cell phone.
• 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.

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