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Covance Sr GLP QA Officer (Remote Possible) in Greenfield, Indiana

Job Overview:

Sr GLP QA Officer

We have a great opportunity for a Sr GLP Quality Assurance (QA) Officer to join our Global QA group in Indianapolis, IN.

This position can be remote.

Covance’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

An individual in this role verifies 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 multiple business lines (e.g., Safety Assessment/Chemistry/NCFS/DTS). Responsibilities include supporting client visits and performing QMS audits without supervision. A Senior GLP/GCP QA Officer leads internal and external facility and supplemental inspections, leads process improvement and harmonization efforts that promote best practices, and prepares and delivers quality and regulatory training. At this level an individual will start to gain experience in assisting with regulatory inspections under supervision.

  • Performs protocol, data, report, and in-lab phase inspections for multiple business lines 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/review (internal/external) and report finalization.

  • Performs SOP reviews and initiates or updates SOPs as appropriate

  • Participates in internal and external facility and supplemental inspections.

  • Prepares and delivers quality/regulatory training.

  • Leads process improvement and harmonization efforts that promote best practices.

  • Support client visits including introductions, data reviews, tours and debriefs without supervision *

  • Support regulatory visits under supervision *

  • Supports QMS audits including introductions, data reviews, tours and debriefs without supervision

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Education/Qualifications:

Level of education required (or experience level which may be substituted for level of education).

Professional designations/certifications/licenses required

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

  • Recognized 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 five years' of experience as a quality auditor in a GxP-regulated environment.

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.

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