Quality Control Analyst

About This Role

Quality Control Analysts perform a variety of chemical, biological, or microbial analyses or sampling on raw materials, products, in-process materials, utilities, environmental monitoring, or stability samples. This role supports the company's quality program at a new highly automated drug substance manufacturing facility.

Responsibilities

• Gather data and document test results
• Review test results to ensure compliance with standards; report any quality anomalies
• Comply with all pertinent regulatory agency requirements
• Participate in required GMP training activities
• Maintain laboratory supplies
• Conduct testing and sampling on raw materials, in-process, product, stability, and/or research samples
• Write and revise control test procedures and standard operating procedures (SOPs)
• Complete test records and review data
• Calibrate or verify calibration of instruments/devices prior to use
• Interact with outside customers or functional peer groups
• Engage in exciting projects aligning to scientific initiatives
• Devise or develop new analytical methods and techniques
• Assist in validation of methods
• Partner with internal teams on establishing the transfer of methodology from R&D

Requirements

• B.S in Life Sciences or related field; or equivalent combination of education and experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Important Details

• Locations: Initial: Rensselaer, New York, United States; Permanent: Saratoga Springs, New York, United States
• Work model: Initial: full time, on-site 1st, Mon-Fri, 8am-4:30pm; Permanent: full time, on-site, rotating 12-hour shifts, 7am-7:30pm, 3–4 days per week, includes 1 weekend day
• Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.
• Gowning: Full cleanroom attire (examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)