Chemist - Incoming Quality

Chemist I - Incoming Quality page is loaded## Chemist I - Incoming Quality locations:
Rochester, Michigan time type:
Full time posted on:
Posted 2 Days Agojob requisition :
R002769

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
** Job Description Summary
** The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.
** Job Description
** Scope of Authority *- span of control* *(work unit, site, department, division, etc.), monetary value of budget/spend authority* *( capital, operating, etc.), P&L responsibility, etc.
* Typically supports one Par business, at a single site

Key Accountabilities *- key outcomes/deliverables, the major responsibilities, and % of time
* Accountability Responsibilities% of Time Analysis & Testing
* Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
* Uses laboratory software for analyses
65%
Lab Equipment
* Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
* Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
* Under close supervision, learns to troubleshoot basic instrument problems
20%
Investigations
* With guidance, participates in OOS/OOT/NOE and other investigations
* Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor
* May assist in drafting, editing, and reviewing SOPs and laboratory investigations
10%
Training
* Maintains assigned training records current and in-compliance
* May assist in the training of less senior laboratory staff 5%
Compliance
* Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia

I requirements within pharmaceutical manufacturing setting
* Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs
* Follows internal processes related to controlled substancescontinuousSafety
* Follows EH&S procedures to ensure a safe work environment
* Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDScontinuous Total
100%
Qualifications Education & Experience
* Minimal acceptable level of education, work experience and  certifications required for the job
** Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required.
* Some pharmaceutical laboratory experience preferred.

Knowledge
* Proficiency in a body of information required for the job
** e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
** Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
* Basic knowledge of wet chemistry techniques
* Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS
* Competency in Microsoft Office Suite Skills&Abilities
*…