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Analytical/Quality Control Lab Metrologist

Veranova L P
locationDevens, MA, USA
PublishedPublished: 6/14/2022
Science
Full Time

Job Description

Job Description

Discover Veranova

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focuses on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview:

The Analytical/QC Lab Metrologist is responsible for the timely installation, maintenance, repair, calibration, and IQ/OQ of instruments, balances, and other equipment used by the Analytical Development (AD) and Quality Control (QC) groups. This role also ensures Standard Operating Procedures are technically sound and provide full regulatory compliance. This position is critical to supporting high-quality science, operational excellence, and regulatory compliance across both sites.

Core Responsibilities:

  • 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. Trouble shooting or judging the issue for chromatographic systems mainly LC/GC.
  • 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:

Required

  • Bachelor’s Degree in chemistry or a related science with a minimum of 5 years’ related experience
  • Familiarity with LC/GC trouble shooting.
  • Experience in a cGMP environment
  • 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

Preferred

  • Experience in lab equipment such as analytical balance, micro balance, KF, OVEN-KF, NMR, ICP-MS, PSD, XRPD, TGA, DSC, etc.
  • Experience or familiarity with Labware LIMS and the Instrument Manager module
  • Experience or familiarity with Master Control and Veeva
  • Recent relevant experience in bulk pharmaceutical/API manufacturing or specialty chemicals

Our Commitment:

  • Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
  • Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
  • Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
  • Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.

How to Apply:

At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit www.veranova.com to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.

We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.

For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to talentacquisition@veranova.com in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

Important Notice Regarding Recruitment Scams: Veranova is committed to providing professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.

  • Legitimate communications from Veranova will only come from official email addresses using our domain: veranova.com.
  • Legitimate LinkedIn communications will only come from active Veranova employees.
  • Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).
  • Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).

All your information will be kept confidential according to EEO guidelines.

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.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

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