Analyst II, Quality Control (Night Shift)

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.

Job Responsibilities

Core 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.

Experience & Education

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.

Work Schedule:

Night Shift - 6pm - 630am with a 12-hour rotation on a 2 nights on, 2 nights off, 3 nights on, 3 nights off with the rotation starting over.
The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This role requires the ability to provide 24/7 on-call support as needed.