Covance GLP QA Officer I in Harrogate, United Kingdom

Job Overview

Quality Officer I - GLP

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

We are recruiting for our Early Development Chemistry team in Harrogate and are currently seeking to hire a Quality Officer I to help support the team.

This is a full time time position, based in our early development unit in Harrogate, North Yorkshire.

About the Job

As a GLP QA officer, you will verify compliance to applicable Standard Operating Procedures (SOPs) and regulations (GLP and/or GCP) by performing study protocol, data, report, in-lab phase inspections where applicable, for a specific study type. You will be gaining experience by participating in internal facility and/or supplemental inspections (under some supervision) and begin to review SOPs. You will identify opportunities for process improvement and harmonization efforts to promote best practices, and will be starting to gain experience in delivering training in basic quality/regulatory matters

Essential Job Duties .

  • Performs protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable SOP and regulatory requirements.

  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.

  • Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).

  • Notifies management of service failures.

  • Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.

  • Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization.

  • Performs SOP reviews.

  • Starts to participate in internal facility and supplemental inspections, under supervision.

  • Starts to deliver basic quality/regulatory training, under supervision.

  • Identifies opportunities for process improvement and harmonization efforts that promote best practices.

  • Performs other related duties as assigned.

What we’re looking for

To be successful in this position, you will need to hold aBachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science). Recognised qualifications to support proficiency in basic numeracy and literacy (precise details will be dependent on the country of location).

Additionally, you will need to demonstrate:

  • Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)

  • At least 1 year of experience as a quality auditor in a GxP-regulated environment

Get to know Covance

Covance, the drug development business of LabCorp, is the world’s most comprehensive drug development services company. Because of our broad experience, from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team’s impact on healthcare is remarkable. Through their everyday work they’ve supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

The Covance team is driven by an energized purpose to improve health and improve lives across the globe. Here, you’ll work alongside exceptional people who each play an important role in bringing new scientific discoveries and therapeutic area advancements to life. And, because we span the drug development spectrum, you’ll directly impact a wide-range of initiatives as you explore unique career paths and discover your extraordinary potential.

Get ready to make a difference as we speed the delivery of groundbreaking therapies and improve lives of countless individuals.

EEO Statement

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Education / Qualifications

  • Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)

  • Recognised qualifications to support proficiency in basic numeracy and literacy (precise details will be dependent on the country of location).

  • Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)

  • In exceptional circumstances, directly relevant previous experience may be substituted for degree requirements.

Experience

All candidates would be considered on their own respective merits,

but the following is the typical level of experience held by individuals in this position:

At least 1 year of experience as a quality auditor in a GxP-regulated environment

Job Number 2018-21622

Job Category Quality Assurance

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.