Job description

Job description

The Lab Analyst must be proficient at basic analytical techniques such as pipetting, weighing, drying, filtering, etc.; and must have industry experience (preferably in an FDA regulated industry) with one or more techniques in automated instrumental analysis (HPLC, GC, dissolution) or wet chemical analysis (compendial methods).
The Lab Analyst performs testing of any and all samples submitted to the laboratory in a cGMP compliant manner following written procedures and good documentation practices. The Lab Analyst could be required to write or revise SOPs, analytical procedures, and analysis reports, at the discretion of quality unit. Analyst provides guidance to blenders, processes samples and prepares records, charts, and graphs of results for presentation. Analyst performs incoming inspection testing of raw materials. Must ensure that the product meets specifications. Performs all tasks in a safe manner observing cGMP and quality standards. Must be results focused and oriented toward accomplishment of team and organizational goals. Must be able to work flexible hours to include overtime when needed.

Duties:

• Perform testing in accordance with written procedures for: stability samples, raw materials and packing components, in-process manufactured product and finished product.

• Perform testing to support method validations, method transfers, process and cleaning validations.

• Review and countersign worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.

• Qualify in-house reference standards.

• Perform daily standardization and performance verifications on laboratory equipment.

• Comply with site wide procedures including but not limited to change control, documentation, deviation and OOS reporting, cGMP compliance and safety.

• Obtain and perform quality tests on samples of raw materials, intermediates and finished goods using the full spectrum of analytical tools and technology available. Record data, analyze and present analysis to the proper personnel.

• Conduct special testing and analysis in conjunction with new product development, trouble-shooting of complaint samples and investigation/analysis of off-spec products and raw materials.

• Ensure samples in the control laboratory are processed fully, accurately and in a timely manner.

• Ability to work from written and verbal instruction.

• Efficient work habits.

• Ability to work with minimal supervision while remaining productive at all times.

• Ability to stay positive and calm in difficult and/or trying circumstances.

• Some administrative activities may be required as needed

Requirements:

• One (1) three to (3) years of Quality Control laboratory experience in the pharmaceutical/biologics industry.

• BS/BA degree in chemistry related scientific discipline, preferred. All experience must reflect working in a cGMP environment.

• Ability to work efficiently in a fast-paced, high volume environment

• Detail oriented, Quality Oriented

• Ability to follow written procedures

• Ability to interact and work with team members

• Record data accurately

• Ability to apply computer skills covering word processing, spreadsheet analysis

• Ability to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations.

Job Type: Full-time

Pay: $23.00 - $24.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Overtime

Ability to commute/relocate:

• Walton, KY 41094: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Chemical Manufacturing: 1 year (Required)
• Industrial Chemicals: 1 year (Required)

Work Location: In person

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