Quality Control Chemist
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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : [click to reveal website link]
Job Title
Quality Control Chemist
Job Description
Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (PPL Pharma Solutions Riverview LCC), located in Riverview, Michigan, is seeking a qualified Quality Control Chemist II to join our Quality Control team. The Quality Control Chemist II is responsible for providing analytical chemistry support for the facility.
Key responsibilities.
- Perform testing on intermediates and final products to meet production/client timelines.
- Support manufacturing operations through the testing of raw materials and starting materials as required to meet production timelines.
- Test reference standards and stability samples.
- Document sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms. Verify data with second quality team member as required. Maintain all records as required to maintain compliance.
- Assist in the preparation of new and revised documentation as required.
- Provide support in the maintenance and calibration of laboratory analytical instrumentation.
- Assist in the maintenance of the QC laboratory through routine housekeeping, as well as keeping personal bench area and desk organized.
- Act as the primary QC contact for the Production team and/or Program Manager for any given project or synthetic step.
- Provide necessary training and guidance to newer employees on GMP issues and analytical issues.
- EDUCATION/EXPERIENCE.
- Bachelor's degree in Chemistry or Biochemistry or equivalent.
- Minimum five (5) years of experience in pharmaceutical quality control in a cGMP environment.
- Hands on thorough knowledge of analytical testing and instrumentation specifically HPLC, GC, Residual Solvents, KF, solid state testing.
- Familiarity with GMP requirements/regulations.
- job competencies.
- Excellent organizational and planning skills.
- Strong written, verbal, and interpersonal communication skills.
- High attention to detail.
- Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
- job conditions.
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Physical Demands:
- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
- Long periods of standing and walking can be expected in this position.
- This position may require long periods of sitting, typing, computer entry or looking at a computer.
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- Work Environment:
- Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
- Potential limited exposure to hazardous chemicals.
- Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position