Quality Control Chemist
Quality Control Chemist
Job Number: 19-02615
Job Number: 19-02615
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Control Chemist for our client in Pearl River, NY.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Consistently performs routine and more complex analytical chemistry activities with a high degree of independence.
- Demonstrates technical expertise in one or more analytical areas.
- Develops and validates analytical methods relating to the support of marketed products.
- Compiles validation data into comprehensive reports.
- Transfers analytical methods in support of new product launches and existing marketed products.
- Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes to APIs and critical excipients used in marketed products.
- Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize API’s, excipients, in-process materials, and finished products.
- Applies statistics to data analysis and the design of experiments. Generates analytical data for the purposes of determining the level of correlation to measurements that use Process Analytical Technology techniques.
- Accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements
- Conducts assays In addition to high technical competence understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development.
- Continues to expand breadth of technical expertise.
- Analyzes results Analyzes and interprets project/study/investigation/review results independently.
- Makes tactical decisions independently based on the results.
- Learns to develop project strategy in consultation with supervisor.
- Trains & Mentors Trains more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor.
- Mentors analysts by providing technical knowledge and support in resolving technical problems. Takes initiative; seeks out additional assignments, etc.
- Lab Support Designs, develops and evaluates plans for projects/studies/ investigations/reviews.
- Completely responsible for planning and execution of all tasks needed to achieve routine goals.
- Seeks advice on planning from supervisor when there are priority conflicts.
- Begins to consider and consult with supervisor in area of long range planning for further development of the function.
- SOPs and Admin Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.
- B.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline.
- M.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline.With a B.S., minimum of 8 years of relevant Quality experience, preferably in the bio/pharmaceutical industry.
- With a M.S., minimum of 6 years of relevant Quality experience, preferably in the bio/pharmaceutical industry.
- Strong background in relevant analytical methods and techniques
- Analytical Techniques & Methods In addition to high technical competence understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand breadth of technical expertise.
- Documentation & Systems Use Ability to interpret and document test results according to standard operating procedures using all standard Quality systems; strong background using LIMS may be desirable.
- Advancing Methods Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.
- Extensive practical and solid theoretical knowledge
- Applicable compliance guidelines of the FDA or other regulatory bodies
- Test procedures such as USP, NF and ASC, and relevant SOPs.
- Ability to review workload and determine most efficient and effective testing plan schedule.
- Ability to leads teams comprised of immediate group members or to work cross functionally, if necessary.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Status: Contract/Temporary