Job Description

To analyze and / or test under cGMP, raw materials, intermediates and finished products by applying validated or compendia methods.

Position context -

• Performs/Applies knowledge and skills to diverse reactions.
• Release testing of products per current compendia, regulatory and corporate quality systems, and principles.

Key areas of accountability/responsibility

• Performs analysis in the laboratory with minimal supervision.
• Prepares standards, mobile phases, and reagents.
• Calibrates and monitors laboratory equipment (HPLC, GC, ICP, etc.)
• Analyzes raw materials, intermediates, stability samples and finished products for required tests by various analytical and instrumental methods.
• Performs calculations, collects and prepares data for evaluation.
• Keeps supervisor informed of work status
• Investigation of OOS results under guidance of senior staff
• Maintains good documentation practices. SHE Duties & Responsibilities: Display and promote positive safety behaviors at all times; use proper personal protective equipment, appropriate safety tools, equipment and procedures to ensure that self and others go home safe each day; that area and equipment operate at the highest safety levels; that all people in the area (lab techs, quality personnel, maintenance, visitors, contractors, etc.) comply with the safety directives and keep the area neat and clean.
• Ensures incidents are investigated, reported, and risks are assessed in a timely basis.
• Acts in such a way that safety awareness & accident prevention are considered in performing all tasks
• Shows leadership by working to SHEQ standards and encouraging colleagues to work to the same standards.
• Shows leadership by working to support Customer Commitments and encouraging colleagues to work to the same standards.
• Supports plant and corporate initiatives as outlined in the manufacturing plan.
• Responsibility for correctness of the determined results.
• Work according to SOP’s and Specification sheets.

Complexity of the position-

• Demonstrate the ability to learn and perform lab specific analytical methods
• Complete analysis on raw materials and finished products within an agreed upon turn around time.
• Ensures SOP’s and specifications are up to date and in compliance with current Compendia and updates them if required.
• Performs and documents all work associated in adherence with cGMP guidelines.

Knowledge and educational level -

• Bachelor’s degree in a relevant Scientific discipline preferred, associate’s degree required.
• Broad / General knowledge of quality control techniques and methods.
• Broad understanding of safety, laboratory hygiene and GMP rules
• This position is overtime eligible. The schedule may be structured with a required overtime component built-in. Candidates must be able to work shifts, weekends, overtime (including coverage) and holidays as required. All candidates, both internal and external, applying for this position understand that overtime may be required and adjusted based on business needs and to ensure continued safe operations.

Required level of experiences -

• 0-3 years of lab experience
• Experience in Microsoft Office (outlook, word, and excel)

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