Quality Specialist III - Specification Building

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summary:

Prepare and review Raw Material and Finished Product Specifications (MLPs) for Commercial Operations and Pharmaceutical Development Services groups. Works closely with Business and Project management to create new and revised specifications. Must have a good understanding of analytical testing procedures and interpreting USP/EP/JP Compendia.

Essential Functions:

• Creates and maintains Sample Manager Laboratory Information Management System (LIMS) specifications, Workflows, and Certificates.

• Works closely with Business and Project Management to create Raw Material and Finished product specifications.

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• Creates new Raw Material GMIDs in SAP.

• Maintains/updates Regulatory Documents for all raw materials.

• Evaluate the regulatory and current Good Manufacturing Practices (cGMP) impact of proposed materials for qualification of alternate/new suppliers.

• Bachelors Degree in Chemistry, Biology, Engineering or relevant science preferred.

• Minimum of 3 years experience in a GMP facility.
• Equivalent combinations of education, training, and related work experience may be considered.

• Extensive knowledge of GMP

• Excellent problem solving and writing skills.

• Strong Proficiency in Microsoft Office Suites

• Ability to work on multiple projects simultaneously.

• Strong attention to detail

• Requires a basic understanding of the practices, principles and theory of GMP Services. Must be able to identify and analyze unique problems.

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.