Job Description

Company Description

Job Description

·       Revises and reviews metrology-related protocols and IQ/OQ to ascertain proper functioning of the instrumentation.  Ensures that appropriate documentation for the instrument calibration program is in place for compliance with regulatory expectations.

·       Schedules, executes and supports instrument calibrations and preventative maintenance in such a way so as not disrupt the analysts using the instruments.  Responsible in the assignment of instrument custodians, assuring instrument maintenance and usage logbooks have been maintained.

·       Negotiates and manages contracts with external vendors and contracted services as required.  Oversees the work of contracted personnel to install/modify equipment and systems in accordance with the specific needs of the AD and QC groups while meeting all cGMP and USP requirements.

·       Keep abreast of instrument validation requirements to ensure compliance with respect to USP and cGMP requirements.

·       Provides assistance in internal and customer audits by providing relevant, up to date documentation related to calibration, qualification and maintenance of appropriate analytical instrumentation used by the analytical groups.

·       Leads the process to evaluate, purchase and install new instrumentation. Interacts with internal and external vendors to ensure the proper instrumentation is identified to support the needs of the business.  Evaluates and recommends appropriate application of new software packages as well as upgrades of software/firmware/hardware.

·       Directly involved with and supports investigations that are instrument related.
Conducts all work in compliance with USP and cGMP standards and all other appropriate Federal, state and local regulations.

Qualifications

·       Bachelor’s Degree in chemistry or a related science with a minimum of 5 years’ related experience 

·       Familiarity with USP and cGMP regulations

·       Ability to exercise independent judgment in the application of scientific principles pertaining to analyses as related to this business and operation

·       Proficiency with computers and other software packages relevant to installation, modification, calibration and qualification of instrumentation systems and equipment

·       Strong communication skills; written and verbal. 

·       Possess strong organizational skills

Additional Information

Skills/Experience Valued but not required:

·       Experience in a cGMP environment

·       Experience or familiarity with Labware LIMS and the Instrument Manager module

·       Experience or familiarity with Master Control and Trackwise

·       Recent relevant experience in bulk pharmaceutical/API manufacturing or specialty chemicals

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

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