Job Description
A fantastic contract opportunity for an experienced QC Analyst confident in Chemistry tests such as HIAC, Polysorbate, Protein Concentration, Sub Visible Particle testing and general test methods including pH, Appearance, Colour, Clarity, Osmolality, Moisture and Device testing.
Responsibilities:
* Plan and perform analyses with great efficiency and accuracy.
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
* Report, evaluate, back-up/archive, trend and approve analytical data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives and projects that may be departmental or organizational in scope.
* Review protocols and perform assay validation and equipment qualification/ verifications when required.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
* Contribute to regulatory filings.
* Conduct lab investigations as necessary.
* Ccoordinate LIMS data for commercial and import testing on site where applicable.
* Represent the department/organization on various teams. May train others.
Requirements:
* Bachelor's degree in a Science related field is required.
* 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Desirable Skills:
* Experience with analytical techniques such as Compendial testing.
* Proficiency in the use of Microsoft Word, Excel etc.
* Strong communication and technical writing skills.
* Investigation skills.
* Detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
* Self-starter capable of working on own initiative.
* Strong teamwork skills.
* Proven track record of meeting deadlines.