Analyst II, Quality Control (Night Shift)

Brief Job Description

The position involves on-the-floor sampling, data review, and documentation in compliance with cGMP standards. The individual will conduct testing on a variety of samples, including finished products, raw materials, stability, in-process materials, and water systems. Strong attention to detail, adherence to quality standards, and the ability to work autonomously in a regulated environment are essential.

Responsibilities

• Performs testing on a range of samples including finished products, raw materials, stability, in-process and water samples.
• Maintains and troubleshoots testing equipment.
• Supports laboratory investigations, QC method and SOP updates.
• Executes laboratory test protocols to support development and validation activities.
• Responsible for QC data review.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Able to take direction and correction when learning procedures and performing analysis.
• Participates in and contributes to the team atmosphere.
• Self-motivated: able to complete all tasks assigned and able to self-assign work without immediate supervision, when appropriate.
• Able to knowledgeably and safely handle hazardous materials.
• Good verbal, written and interpersonal communication and organizational skills.
• The ability to learn and adapt quickly to new priorities and/or situations.
• This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.
• This role may require collaboration and communication within the team and with operations groups/QA.
• The role may require individuals to autonomously perform tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site, including data review and on-the-floor sampling.

Minimum Qualifications

• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Good problem-solving skills.
• Proficient in math, laboratory and computer skills.
• Understands basic statistics and quality control terminology.

Preferred Qualifications

• Bachelor's degree in chemistry, biology or a related field.
• QC chemistry laboratory experience in the pharmaceutical industry.
• Working knowledge of laboratory equipment (including HPLC), operations, and safety.

Physical & Work Environment

• Work is performed onsite in a cGMP manufacturing and laboratory environment, including cleanrooms classified up to Class 100 (ISO 5) aseptic areas.
• Requires gowning and adherence to aseptic behavior requirements for the duration of cleanroom activities.
• Requires standing, walking, bending and reaching for extended periods, and the ability to lift up to 25 pounds.
• Requires the ability to work a rotating 12-hour night shift, including weekends and holidays as scheduled.

Schedule

• Night Shift - 6pm to 6:30am with a 12-hour rotation on a 2 nights on, 2 nights off, 3 nights on, 3 nights off schedule.
• This role requires the ability to provide 24/7 on-call support as needed.

Pay & Benefits

• Target base pay hiring range: $60,000.00 - $86,250.00 per year.
• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Healthcare benefits including medical, dental and vision.
• Family building benefits.
• Life and disability insurance.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Tuition reimbursement and support for caregiving needs.