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QC Formulations Chemist in Lawrence, KS at Grafton Staffing Companies

Date Posted: 3/2/2019

Job Snapshot

Job Description

                              QC Formulations Chemist




The QC Formulations Chemist is responsible for developing pharmaceutical and medical device formulas, demonstrating stability, sourcing initial raw materials, and transferring the manufacturing of the formula/product to manufacturing. The QC Formulations Chemist conducts cGMP laboratory testing to support formulation development. Testing includes sampling of raw materials, and HPLC assays, in addition to various USP tests. This position requires attention to detail, requiring a proactive individual who is capable of assisting in new assay development and product transfers. The QC Formulations Chemist will be responsible for generating and revision laboratory procedures, new master batch records, performing audits, and analyzes data for compliance. The QC Formulation Chemist reports directly to the QC Manager.

Roles of Position:

•     Formulation: Develops new formulas, assists in the transfer of formulas, and generates stability protocols and data to support expiration dating on products.

•     Chemist, Lab Tech, QC Line Testing,  and Clean/Sanitization of  Lab:Performs  testing and performs  various  activities in support of these job roles, develops methods, and works with lab team to ensure compliance to procedures. 

  • Assumes accountability for work performed. 
  • Assists in peer review of reports and documents for compliance to requirements
  • .Reviews and approves data for compliance. 
  • Generates reports in support of the Quality System, as required.
  • Provides chemical related safety support to the safety officer and handles waste stream related to chemical waste.

•     Facility Maintenance: Performs this job role in support of laboratory equipment and assumes accountability for the work performed. Actively review reports and documents for compliance to requirements . Assists the QC Manager in tracking calibration for the site.

•     Validation: Supports validation activities in manufacturing. Generates and executes protocols for product transfer and method validation.

•     Purchasing: Uses the purchasing system to procure laboratory and validation supplies.

•     Actively uses the OCR System to generate or revise document, as needed.

•     Provides support for continuous improvement and Kaizen events and projects.

•     Supports the non-conformance system through reporting of Non-conformances and supporting Quality in investigation activities. Provides reports and communication based on investigation findings


Required Qualifications


Minimum Requirements: BS/MS in science major or extensive equivalent experience, 2 years chemistry experience in a pharmaceutical, medical device facility, or research facility/university. Education and experience in chemical interactions, specific to understanding formulation requirements. Experience in ISO standard execution, cGMP and Quality Systems.

SKILLS/QUALIFICATIONS: Wet-chemistry, HPLC Instrumentation, method development, calibration and lab equipment maintenance. Skills in a variety of analytical instrumentation preferred.