Quality Specialist III (GMP Investigation)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary:

Investigates and observes Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product registrations are followed and maintained. Conducts investigations of batches, preps, lots, equipment, and facilities in accordance with the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA and DEA requirements.

Essential Functions:

• Investigates deviations to identify the probable root cause of the incident and corrective actions.
• Determines if batch is acceptable to release, or to deny release, what corrective actions are necessary and provide follow-up to ensure that corrective actions have been implemented.
• Assures review of incident by appropriate level of management and must notify management of serious incidents that require management’s review and action.
• Conducts GMP inspections of facilities to assure compliance with the current GMP regulations.
• Performs housekeeping inspections to assure Operations is maintaining work areas in an orderly and clean manner.
• Conducts cleaning inspections of equipment and areas.
• Recommends changes to batch records for clarification and compliance. Assures that operators are following written instructions and methods.

Required Qualifications:

• HS Diploma or GED is required
• Bachelors Degree in Chemistry, Biology, Engineering or relevant science preferred.
• Minimum of 3+ years' experience in Records, Investigation Writing, QC, QA, Analytical Development, Process Engineering, Engineering services or manufacturing is required
• Requires a basic understanding of the practices, principles and theory of GMP Services. Must be able to identify and analyze unique problems.

Equivalency:

• Equivalent combinations of education, training, and related work experience may be considered.

Knowledge, Skills and Abilities:

• 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

Physical Requirements:

• 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.

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