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Quality control associate

Recruitment by Aphex
Quality controller
Posted: 11 January
Offer description

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

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