Analytical Chemist

Proclinical is seeking to hire an Analytical Chemist located in Oak Hill, NY. In this role, you will support Operations by testing / analyzing raw materials, packaging components, intermediate batches, packaging and finished products as required by specifications, internal standards and compliance legislation in a timely manner.

Job Responsibilities:

• Carry out the testing/ analysis of raw materials, packaging components, intermediate batches, packaging, and finished products in a timely manner, as required. Support routine raw material, packaging material, bulk and finished product disposition decisions in a timely manner.
• Follow all applicable reduced testing programs as well as annual full testing using USP/NF, FCC, JSCI Pharmacopoeia and methodology.
• Check all relevant documentation as part of the analysis of raw materials (e.g. CoA, tank cleaning certificate, hose cleaning certificate, etc) and communicate with the responsible person in case of missing / insufficient documentation
• Data entry of test results in laboratory notebooks and in internal data systems (SLIMS, SAP, etc)
• Ensure that all events with a potential impact on Product Quality (+ Safety, Efficacy, Stability), Quality Compliance, EHS and Laboratory Cycle Time are immediately escalated to the responsible senior personnel / management (OOS, OOT, HiPo, DI, equipment breakdown, etc)
• Support the immediate trouble shooting and investigation of out of specification results
• Support method and/or product transfer and NPI activities and execution of test method validation protocols
• Preparation and documentation of test solutions and standards and their proper storage.
• Clean, maintain, calibrate and support the validation of laboratory equipment.
• Order chemicals and consumables from the appropriate supplier.
• Perform tasks according to the instructions of the reporting manager which are in scope of role
• Participate in / complete all assigned and mandatory trainings and complete evaluations on time
• Perform all assigned tasks in accordance with all applicable legal health and safety requirements, regulations, global and internal standards
• Participate with cross-functional teams and support Operational Excellence initiatives and programs (e.g. eLM)
• Lead by example and demonstrate positive behaviours in the field of EHS and Quality and participate in initiatives to improve the site culture in quality and safety

Skills and Requirements:

• Bachelor of Science Degree
• Area of Specialisation Science, Mathematics, Technology
• Science degree in applicable scientific discipline, or equivalent on-the-job experience.
• Working laboratory experience, preferably with FMCG experience.
• Working knowledge of Quality standards, GLP and GMP requirements.
• Working knowledge of validations, calibration systems, and instrumentation.
• Working knowledge of applicable policies and procedures.
• Problem solving/continuous improvement skills.
• Developed skills in coaching, interpersonal communications, team building and training facilitation.
• High level of computer literacy with working knowledge of Microsoft Word, Microsoft Excel and Laboratory Information System (SLIMS).
• Ability to interact with all levels of the organization.
• Experience in implementing Quality Systems in regulated environments.
• Experience in writing, reviewing, and revising SOPs.
• Excellent written and oral communication
• Ability to set priorities and work on multiple projects simultaneously.
• Ability to work and succeed in a team-based environment.
• Flexibility to work extended hours (including weekends) to achieve results as needed
• Familiar with statistical software (ex Statistica)

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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