Careers
Chemir Analytical Services is a growing company. We are current seeking
to fill a variety of positions. Please forward resume, cover letter and salary history to: hr@chemir.com.
GXP Review Specialist
This position will review various types of laboratory data to ensure documentation is complete, accurate, and compliant with all aspects required of a cGXP established laboratory. Conduct activities in accordance with USP/NF, EP, BP and JP Pharmacopeias, compendia or other Standard Testing Procedures (Chemir or client methods); following cGXP and company policies.
Responsibilities
- Review data pertaining to General Testing of Samples, Method Developments, Validations, Qualifications, Transfers and Special Studies, ensuring compliance to written SOP, protocol, method, or work instruction
- Review laboratory notebooks and all related documentation (e.g., chromatograms, spreadsheets, spectra, etc.)
- Review data regarding analytical testing in accordance with USP/NF, EP, BP and JP Pharmacopoeias, compendia or other Standard Testing Procedures (Cyanta or Client Methods) to ensure results are accurate and complete.
- Review protocols and reports as necessary
- Review reports and associated raw data from subcontracted laboratories
- Review Out of Specification (OOS) reports
- Review Instrument Qualifications and Calibrations
- Perform miscellaneous tasks that contribute to the proper operation of the Laboratories
- Achieve customer satisfaction through timely data generation and reporting, compliance with the quality system, and communication to supervisor
- Become an expert in the operation of routine laboratory instrumentation
- Participates in the creation or revision of Chemir SOPs, procedures, policies or systems
- Ensure that documentation of laboratory work is maintained and reviewed in an appropriate manner
- Oversee the distribution of audited documentation and reports associated with assigned projects and tasks
- Develop leadership skills by communicating status of lab work
- Communicate to management any problems found during data review that might affect laboratory operations
- Mentor and train other reviewers on job functions
Requirement for the Position
- Familiarity with the following instruments/techniques: Balances, pH meters, preparation of standard, reagent, and mobile phase solutions, preparation of dilutions, handling of volumetric glassware, and similar techniques.
- Familiarity with the following types of assays: osmolality, viscometry, physical appearance, mass uniformity, hardness, FTIR, titrations, etc.
- Familiarity with the following techniques: LC, GC, ICP/AA, LC/MS, GC/MS.
- Knowledge of GXPs and ICH guidelines.
- Must be able to execute data review with minimal supervision.
- Ensure that documentation of work for assigned projects and tasks is maintained and reviewed in an appropriate manner.
- Report / escalate errors to appropriate department for resolution.
