Job Description
Up to 80K base salary + Excellent Benefits - Room for Growth - Leading Manufacturer in the pharma industry This Jobot Job is hosted by: Gabriel Ozuna
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Salary: $75,000 - $80,000 per year
A bit about us: We are a leading manufacturer and distributor of over the counter pharmaceutical and consumer healthcare products with a commitment to improving peoples lives every day.
Why join us?- We value our employees and we foster an environment where people are passionate about their work.
- Competitive Pay
- Excellent Benefits
- Stable organization with a national presence
Job Details Job Qualifications:
BS in Chemistry / Biochemistry
Minimum 5-8 years in FDA regulated environment working in QC laboratory.
A foundation in analytical technique, with hands-on sample preparation and operation of analytical equipment and software required.
Strong HPLC experience required with trouble shooting skills.
Experience with GC, FTIR, UV Spec, ICP and other analytical instrumentation.
Experience with wet chemistry.
Experience with data analysis (MS Excel) and proficiency with MS Word required.
Experience with raw material, stability, in-process, and finished product testing.
Demonstrate good laboratory practices.
Participate in research and development projects
Strong verbal and written communication skills
POSITION RESPONSIBILITIES:
Perform analysis in the functional areas of analytical testing using modern analytical equipment such as HPLC, FTIR, UV, GC, ICP, as well as Wet Chemistry using titration techniques.
Perform troubleshooting and maintenance on critical lab instruments (HPLC, GC, ICP, etc.)
Provide analytical testing in support of production, analyzes Raw Material, In-Process, Finished product, Stability samples and investigation samples and analyzes and interprets the test data and document result in a timely manner.
Thorough understanding and compliance with FDA cGMPs / cGLPs / USP / ICH / SOPs / Test Methods and other recognized standards.
Support and be the lead in Analytical and Chemical test method development and test method validations as necessary.
Writing of SOPs, test methods, study protocols, reports and reviews.
Training of lab analysts on analytical test method procedures and usage of equipment and documentation.
Share in the responsibilities of housekeeping (i.e. glassware, waste, retains, lab waste disposal, etc.).
Communicate lab test data, data review, and reporting of OOS / QR / OOT test results to the lab manager.
Provide ideas/feedback for areas where efficiency can be implemented in the lab through the 5S process improvement program.
Support all general safety, and pharmaceutical compliance requirements
Coordinate with calibration services in the upkeep of lab instrumentation
Initiate and complete analytical test methods associated with raw materials, finished products, and lab instrumentation.
Mentor other chemists in the QC laboratory
Lead laboratory investigation efforts and draft final reports for review by management
Assist with annual management review metrics for QC laboratory functions.
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