Proclinical is currently recruiting for an Associate Chemist with a global pharmaceutical company located in St. Louis, MO. Successful candidate will support Operations by analyzing raw materials, intermediate batches, packaging and finished products as required.
- Responsible for trouble shooting and investigating out of specification results.
- Perform analytical testing on all incoming Raw Materials as per our reduced testing program as well as an annual full testing using USP/NF, FCC, Pharmacopoeia and methodology.
- Responsible for the disposition of raw materials, intermediates, batches, and finished products in a timely manner.
- Data entry of test results. Investigate out of specification results.
- Support method and/or product transfer and NPI activity as necessary.
- Prepare, document and maintain test solutions and standards. Maintain, calibrate, and validate laboratory equipment. Ensure that GMP, Quality, Healthy & Safety are considered in all aspects of role. Perform other duties as directed by QC Specialist or QC manager.
- Routine testing of raw material, bulk batch, packaging and stability samples.
- Authority to notify Operations in manufacturing or filling processes if a problem affecting the quality of the product has been discovered. Authority to initiate investigations in quality related issues.
- Authority to quarantine bulk or finished products if the need arises. Investigate out of specification an out of trend data and recommend CAPA.
- Participate on cross-functional teams. Comply with all safety procedures and policies. Participate in Operational Excellence initiatives and programs. Incorporate Lean Sigma/Lean Lab principles into ways of working.
Skills and Requirements:
- BS degree in a scientific discipline in Chemistry, Biochemistry, Engineering, or other science field.
- Associate Chemist I: 0 - 3 years of relevant experiences in a pharmaceutical development or quality control environment.
- Knowledge of general and analytical chemistry.
- Base level to ensure understanding of problem solving and analytical thinking.
- 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.
- Development skills in coaching, interpersonal communications, team building and training facilitation.
- High level of computer literacy.
- Ability to interact with all levels of the organization. Experience in writing, reviewing and revising SOPs.
- Excellent written and oral communication. Working knowledge of Microsoft Word, Microsoft Excel and Laboratory Information System (LIMS).
- Ability to work and succeed in a team-based environment. Flexibility to work extended hours (including weekends) to achieve results as needed.
- Writing, communication skills and experience using analytical equipment. Technologies include those in the disciplines of Chemistry or other Biological Sciences.
- Ability to be follow established procedures.
- Ability to be flexible, understand risk, and using analytical mindset to troubleshoot.
- Ability to continuous improvement.
- Strong organizational and communication skills and attention to detail.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.