Job Details

Therapure Biopharma
Job title

QC CHEMISTRY DATA REVIEWER

Employer
Therapure Biopharma
View Employer Profile
Job Type
Full Time
Salary
not disclosed
Location
Mississauga
, Ontario
Date Posted
26/11/2013 - 10:15
Closing Date
26/12/2013 - 10:15 PAST CLOSING DATE
Job Description

Summary: 

Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services to clients for the development, manufacture, purification, and packaging of therapeutic proteins. Responsible for reviewing documentation and test results produced in the QC Chemistry Laboratory to ensure compliance with established SOPs, Protocols, and Good Manufacturing practises. In addition responsible for preparing CofAs and trending reports for QC product results and test controls.

Education & Qualifications: 

- Bachelor’s degree or college diploma in a scientific discipline with 3 years related experience in a quality lab environment (pharmaceutical preferred)
- Strong understanding of GMP.
- Extensive knowledge of analytical tests.
- Some knowledge in protein analysis such as BCA, SDS-PAGE, and ELISA.
- Data Review, statistics and trending report preparation with knowledge of MS Word, Excel and Outlook.
- Knowledge of compendial test requirements, US and Europe Pharmacopea.

- Candidate must be self-motivated, highly organized and able to work in the fast paced environment.
- Ability to learn the QC test procedures and protocols quickly.

Duties & Responsibilities: 

MAJOR RESPONSIBILITIES:
- Review in-process, final product, cleaning validation/verification test results for completeness and accuracy. Ensure all results conform to specifications, GMP, compendial and regulatory requirements.
- Review Instrument calibration and preventive maintenance documents to ensure all data conform to work orders, protocols and SOPs.
- Verify the entries in the sample log book.
- Periodically review the instrument logbooks for completeness.
- Participate in preparing trending reports for final test results and test controls.
- Participate in verifying USP and EP test method to ensure compliance with current revisions.
- Review test summary sheets to ensure that the test results and associated reference numbers have been transcribed correctly.
- Follow established templates for preparing CofAs for Stability and Final products.
- Consult with Analysts to ensure that the all necessary corrections are made in a timely manner.
- Report to the supervisor immediately any deviations from QC procedures, or other discrepancies that may arise during the review of documents.
- Review completed log books and test result books. Work with QA to archive them properly.
- Perform other document reviews after training to support activities in the QC Chemistry Laboratory.

ADDITIONAL RESPONSIBILITIES:
- Ensure documentations are accurate and up to date.
- Overtime will be required to meet business needs.

Other Information: 

Please do not apply through The PetriDish.

Please email your cover letter and resume to talent@therapurebio.com and indicate which position you are applying for in the subject field.
Only those to be interviewed will be contacted.