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  • Chemist I - Incoming Quality

    Endo International (Rochester, MI)



    Apply Now

    Why Us?

     

    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 compendiaI requirements within pharmaceutical manufacturing setting

    + Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs

    + Follows internal processes related to controlled substances

     

    continuous

    Safety

    + 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 MSDS

     

    continuous

     

    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

     

    _Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing_ _etc._

     

    + Ability to display and analyze data in a logical manner

    + Good verbal and written communication skills as well as good computer skills

    + Attention to details and accurate record keeping

    + Establish and maintain cooperative working relationships with others

    + Solid organizational skills

    + Ability to take initiative, set priorities and follow through on assignments

    Physical Requirements

    _Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc._

     

    + Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals

    + Must occasionally lift and/or move up to 15-25 lbs.

    + Ability to wear personal protective equipment, including respirators, gloves, etc.

    + Specific visions abilities are required by this job include close vision and color vision

    + Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods

    **_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required._

    EEO Statement:

    We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

     


    Apply Now



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    Endo International (Rochester, MI)
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