Quality Control Chemist

Biote; Birmingham (AL); On-site; USD 60,000 - 85,000; Full time

Job summary

Asteria Health in Birmingham, AL is seeking a Quality Control Chemist to join our on-site analytical team. You will support daily operations in the laboratory, perform analytical testing, and help ensure product release quality.

The role requires a four-year science degree, 3+ years in an analytical lab, and familiarity with cGMP. You will document results, assist with CAPA, and contribute to continuous improvement within a fast-paced environment.

Qualifications

• A four-year degree in the sciences, preferably with a Chemistry focus.
• At least three years of practical experience in an analytical laboratory role.
• Experience with cGMP guidelines and related concepts, practices and procedures.
• Ability to ensure accuracy of one’s work.
• Excellent verbal and written communication skills.
• Exceptional attention to detail.
• Multitasking ability to meet deadlines in a fast-paced environment.
• Ability to work independently or as part of a team.
• Strong work ethic and reliability.

Responsibilities

• Perform analytical testing of products to support finished goods release.
• Support cleaning validation activities through analytical testing.
• Identify and document OOS events; initiate CAPA and assess effectiveness.
• Communicate OOS results across departments and investigate lab errors.
• Review SOPs and conduct change controls to revise documents as needed.
• Assist in dissolution testing program and manage sample submissions.
• Perform scheduled cleaning and maintenance of lab equipment.
• Test products for stability at established time points.

Skills

Analytical lab experience

Attention to detail

Communication skills

Multitasking

Teamwork

Education

Four-year science degree (Chemistry focus preferred)

Tools

UHPLC instruments

Laboratory equipment

Job description

We are currently looking for a Quality Control Chemist to join our Asteria Health team based in Birmingham, AL. This person must be based on-site in Birmingham.

Position and Scope

This position is responsible for supporting daily operations in the analytical laboratory. Key qualifications include and a commitment to continuous improvement. The QC Analytical Chemist will support Asteria Health in carrying out the mission of the company. This position reports to the Quality Control Manager.

Essential Duties and Responsibilities

• Perform analytical testing of Asteria Health products to support finished goods product release.
• Perform analytical testing to support cleaning validation activities.
• Identify and document Out of Specification (OOS) events as related to laboratory testing. Initiate Corrective and Preventative actions (CAPA) and conduct effectiveness checks.
• Communicate any OOS results immediately and effectively across departments and investigate for lab error.
• Review laboratory standard operating procedures and conduct change controls to revise and improve documents as necessary.
• Assist in the dissolution testing program. This includes building a sampling schedule and submitting samples to a third-party laboratory in a timely manner.
• Perform scheduled cleaning and maintenance of laboratory equipment as needed.
• Conduct testing of products on stability when required based on established time points.
• Ability to identify and initiate continuous improvement projects in the laboratory.
• Sample incoming raw materials for routine and full compendial testing.
• Perform other Quality Control tasks as assigned by the Quality Unit, such as reviewing continuous room monitoring data.
• Ability to troubleshoot and maintain UHPLC instruments.
• Assist with inventory of laboratory consumables, spare parts and equipment.

Skills and Experience Required

• A four-year degree in the sciences, preferably with a Chemistry focus.
• At least three years (preferred) of practical experience in an analytical laboratory role.
• Experience working with cGMP guidelines and demonstrate expertise in a variety of the field’s concepts, practices, and procedures.
• Assumes responsibility for the accuracy of one’s work.
• Must exhibit excellent verbal and written communication skills.
• Must exhibit exceptional attention to detail.
• Multitasking skills and ability to meet deadlines in a fast-paced environment.
• Ability to work independently but in a team environment.
• Excellent work ethic and reliability.

Additional Notes

• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.
• Must be comfortable working with chemical solvents in a safe manner.
• Must be able to use necessary equipment such as computers, scanners, phone/headset, or other technology devices as assigned.