Quality Control Chemist (Pharmaceutical Testing)

Quality Control Chemist (Chemist II) provides scientific knowledge and support to the company. They have extensive scientific knowledge and have been trained in analytical techniques. They have overall responsibility for the technical conduct of all assigned tests as well as for the interpretation, analysis, documentation, and reporting of results. They are the single point of study control. They assist in writing and helping to validate new protocols, analytical instrumentation, and perform method development. They serve as a master trainer in the company and they consult with clients on technical issues.

Education and experience requirements:

Analytical instrumentation experience required.

M.S. degree (Chemistry strongly preferred) with 2+ years of experience in Pharmaceutical industry

Or

B.S. degree (Chemistry strongly preferred) and 4+ years of experience in Pharmaceutical industry

Essential Duties:

Scientific/General

• Ensure method validation and test controls are adequate to support the test methodology
• Performs routine Maintenance and operates assigned analytical instruments
• Ensure calculations and statistics accurately reflect the raw data
• Prepare and review written procedures including SOPs, STPs, and other protocol test procedures and instructions that will be followed during analysis
• Troubleshoots analytical instrumentation problems, and decides the best course of action to remedy those problems
• Evaluates test results for suitability and designates acceptability
• Ensure final reports accurately reflect the data, results and conclusions of the testing
• Ensure test controls and monitors are accurately recorded and reviewed
• Ensure sample and data traceability are maintained throughout testing
• Continually work to optimize the results of the instruments with new parameters or instrument setups
• Ensure procedures and reports are current with published methods

Quality responsibilities

• Reviews general data quality to determine where changes to methods or procedures could improve quality and throughput

Customer Focus

• Assist with failure investigations for the laboratory
• Meets or exceeds sponsors expectations
• Uphold the Nelson Lab service standard
• Assists with questions from sales, service center, quality and regulatory teams
• Communicates and consults with the team to set up proper test plans and other testing parameters
• Supports client visits, audits and consultations

Project Management

• Work with other sections/functions to manage workflow, validations, and other projects that will improve efficiencies and the sponsor’s experience.
• Work with management team in managing test work flow to ensure sponsor expectations are met.
• Coordinate communication between clients and laboratory staff
• Meet turn around deadlines.

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, ISO 17025 and 9001)
• Familiarity with CFR 210 & 211 and ICH guidelines in support of analytical testing and USP-NG Mono Graphs and General Chapters.
• Reviews general data quality to determine where changes to methods or procedures could improve quality and throughput

Professionalism

• Continually learn and train, review scientific literature, and attend meetings to keep current with new technical and scientific information
• Participate on standards committees
• Perform training for new and existing employees

Competencies of this position

• Technical knowledge in cGMP and Analytical Techniques such as HPLVC, UPLC, IC, chromatography
• Analytical laboratory skills
• Leadership skills
• Good communication skills – written and verbal
• Change advocate
• Adhere to Safety policies and practices
• Attention to detail
• Must be able to multi-task and be self-motivated
• Problem solving – laboratory processes and customer issues
• Must be able to work cross functionally

Work Environment:

This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools and analytical equipment.

Possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.

Physical requirements:

The physical demands described here are a representative of those that must be met to perform the essential job functions.

• Required to stand and traverse 30% of the day to various office and lab locations and 70% of the day working at a computer.
• Must be able to lift up to 45lbs.
• Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.
• Bending, stooping, crouching, crawling and climbing.
• Ability to have full body movement required.
• Occasional push and pull tasks with one or both hands.