Analyst II Quality Control Lab,

About the role

Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods.

Responsibilities

• Conduct chemical and physical testing of raw materials, in-process samples, finished goods, and special project/protocol samples in a timely and appropriate manner.
• Use laboratory instrumentation, including KF Titrator, DSC, HPLC, Particle Size Analyzer and Tensile Tester, along with computer systems to collect, record and analyze data.
• Initiate and perform laboratory investigations and develop CAPAs as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
• Communicate effectively and collaborate with supervisors, peers, and cross-functional teams to support production, improve efficiency, solve problems, reduce costs and improve quality.
• Support preparation for internal and external laboratory audits as required.
• Perform equipment maintenance and calibrations as required.
• May perform other duties as assigned.

Requirements

• Bachelor’s Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years’ experience.
• Basic understanding of laboratory instrumentation.
• Knowledge of cGMP manufacturing and basic chemical and biological safety procedures.
• Proficient with basic computer applications, including email, intranet, online forms, training systems, performance management tools, and self-service applications.
• Must be able to read, write, and converse in English.
• Demonstrates integrity, sound judgment, strong work ethic, intellectual honesty, dedication to quality, eagerness to learn, and drive for continuous improvement and solutions.

Skills

• Integrity and trust
• Work ethic
• Sound judgment
• Intellectual honesty
• Pragmatism
• Courage and conviction

Pay

The estimated base salary for this position is $88,000 - $121,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Benefits

• Medical and dental coverage starting on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits