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Senior quality control analyst

Dublin
Morgan Mckinley
Quality control analyst
€60,000 - €80,000 a year
Posted: 6 September
Offer description

Overview

Principal Recruitment Consultant in Quality Control (Contract & Permanent) — Biochemistry, Chemistry & Microbiology. An exciting contract opportunity for an experienced QC Analyst within the Pharmaceutical / Biopharmaceutical industry to join a leading biopharmaceutical company in South Dublin.


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.
* May contribute to regulatory filings.
* May conduct lab investigations as necessary.
* LIMS data coordination of commercial and import testing on site where applicable.
* May represent the department/organization on various teams. May train others.
* Be proficient in Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing as part of general test methods.


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.
* Strong technical writing experience; experience updating SOPs is desired.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
* Experience with analytical techniques such as Compendial testing would be advantageous.


The successful candidate will

* Be very proficient in the use of Microsoft Word, Excel etc.
* Have strong communication and technical writing 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.


Job details

* Seniority level: Associate
* Employment type: Contract
* Job function: Science
* Industries: Pharmaceutical Manufacturing
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