Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Position Summary:

Manufactures complicated products and completes associated documentation. Contributes to the transfer of new products into Manufacturing. Participates in process improvement projects.

Key Responsibilities:

• Manufacture advanced products and complete batch records following all cGMPs.
• Products include calibrators, controls, buffers, etc.
• Perform in-process assays using clinical analyzers. Review and analyze data.
• Weighing, transferring, and mixing of chemicals as required.
• Perform product filtrations.
• Review and approve completed batch records.
• Maintain and analyze lot histories for trends and discrepancies.
• Analyze data to perform calculations for constituent additions and dilutions.
• Train junior scientists on equipment and procedures.
• May write, review, and modify SOPs, work instructions and reports.
• Maintain, troubleshoot and validate equipment as appropriate.
• Execute process validations as appropriate.
• Participate in process improvement projects to improve efficiencies and support business needs.
• Initiate, evaluate, and draft write-ups for NCARs, OOS's and Variances.
• Keep the department lead or manager updated on all issues.
• Perform other job duties such as small equipment cleaning and autoclaving of small parts using lab autoclave and washer as required.

• BS/BA in life scientific field (biology/biochemistry) with 2-4 years of related experience and/or training preferred. AA degree with 4-6 years of related experience may be substituted.
• Strong lab skills and knowledge of safety precautions.
• Familiarity with Quality System Regulations and ISO 13485 regulations.
• Experienced working with potentially hazardous chemicals and human source materials.
• Must be able to lift 25 lbs routinely.
• May be required to lift up to 50 lbs occasionally.

• Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.

• Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
• Must be organized and diligent to be able to prioritize own and other's work and meet business productivity metrics.
• Must exhibit strong leadership ability.
• Self-sufficient, self-motivated, and focused.

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount