QC Laboratory Investigator
Neopharm Labs Inc
Blainville, QC
The Compliance Specialist is responsible for the final review of Certificates of Analysis and writing investigation reports related to OOS/OOT results. He/she must ensure that the related documents are complete and meet SOP (Standard Operating Procedures) and GMP (Good Manufacturing Practices) applicable requirements. The review of raw data in an OOS/OOT file can be required.

Specific Responsibilities:
Write OOS/OOT inquiries, communicate investigation results to the client and initiate the analysis recovery plan;
Ensure that all data and documents related to these investigations (lab books, annexes, spectrums, chromatograms, calculations, etc.) are verified according to SOPs and GMPs;
Verify the information and results transcription on the analytical fact sheet;
Verify the final certificate of analysis to ensure that the transcription of the information from the analytical fact sheet to the certificate of analysis is adequate and corresponds to the requirements of the customer concerned;
Verify all the data and documents (lab books, annexes, spectrums, chromatograms, calculations, concordance between required and used methods, etc.) related to the OOS/OOT (if applicable) and ensure that SOPs and GMPs are respected;
Ensure that all documents required by the client are attached with the reviewed files;
Keep all documentation relevant to its activities up to date;
Organize his/her work in a way to optimize his/ her time (efficient work performance);
Respect delays and priorities;
Verify transcription of customer requests on the analytical fact sheet;
Ensure that specifications comply with current pharmacopoeias or customer specifications;
Be able to initiate an amendment to certificate of analysis.
Assume other tasks delegated by the superior.

Academic requirements:
B. Sc. in Chemistry (or other related field) or DEC in Chemistry (or orther related field);

Other requirements:
A minimum of two years’ experience in the pharmaceutical field;
Knowledge of Empower 3 is definitely an asset;
Motivated;
Good analytical judgment;
French and English ( able to speak and write fluently)
Ability to Concentrate;
Observation skills;
Availability;
Ease of learning;
Versatility and flexibility;
Integrity.