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 organisational in scope.
* Review protocols and perform assay validation and equipment qualification/ verification's when required.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
* May contribute to regulatory filings.
* May conduct lab investigations as necessary.
* Evaluate lab practices for compliance on a continuous basis.
* Approve lab results.
* May interact with outside resources.
* LIMS data coordination of commercial and import testing on site where applicable
* May represent the department/organisation on various teams. May train others.
Qualifications
* 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.
The successful candidate will:
* Be very proficient in the use of Microsoft Word, Excel etc.
* Have strong communication and technical writing skills.
* Investigation skills
* Be detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
* Be a self-starter and capable of working on own initiative.
* Strong teamwork skills.
* Proven track record of meeting deadlines.
* Experience with analytical techniques such as Compendial testing would also be advantageous