QC Analyst

Hovione•East Windsor, NJ

9d•$28 - $44

About The Position

Join a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites. Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life. You will be responsible to: This is a 3rd shift 9:30pm - 6:00am position. Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.

Requirements

High School diploma (mandatory)
Qualification in a relevant chemistry, analytical chemistry, chemical engineering, pharmaceutical-related or other science-related field (mandatory)
Relevant work experience
Proven practical pharmaceutical or related industry experience in a GMP regulated QC laboratory environment (mandatory)
Technical understanding of GMP practices, analytical theory and techniques
Clear and open communication skills (written and verbal)
Ability and availability to work in shift patterns, as required by business needs
Computer literate with knowledge of the MS Office package AK382
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Nice To Haves

Experience of GMP practices and HSE standards (preferable)
Competent (written and verbal) English (preferable for sites where English is not the first language)

Responsibilities

To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
To maintain good hygiene and housekeeping within the laboratory.
To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
Comply with the high standards in the QC Laboratories.
To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
Assist with audits as required, following the instruction of QC Management.
Undertake any additional tasks to support the laboratory activities as and when required.
Seek out additional information when one feels that the available information is not enough.
Follow all annual performance review requirements, including completion of the self-assessment.
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.

Benefits

Benefits include 401(k), paid time off, leaves, and health coverage (medical, dental, vision), subject to plan terms. Full benefit details are shared upon offer.

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