Quality Control Chemist I

Job Description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality Control Chemist I to join our Quality Control team. The Quality Control Chemist II is responsible for providing analytical chemistry support for the facility.

Requirements

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.
  
  

Key Responsibilities.

• Support manufacturing operations through the testing of raw materials and starting materials as required to meet production timelines.
• Perform cleaning verifications on multi-use equipment using approved methods.
• 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.
• As required, test intermediates and final products to meet production timelines/client requirements.
• Assist in the revision of documentation as required.
• Participate in quality unit projects, including but not limited to supplier certification, methods development, methods validation and training of both quality unit members as appropriate.
• 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.
• As required, perform routine testing on the water system (DI, ice, potable, and QC water), and prepare reports as needed.
  
  

Education/Experience.

• Bachelor’s degree in Chemistry or Biochemistry or equivalent.
• One (1) year of experience in pharmaceutical quality control or equivalent is preferred
• Familiarity with analytical testing and instrumentation.
  
  

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.
  
  

• 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.