We have a great opportunity for a GLP QA Officer III to join our Global QA group in Madison, WI.
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 all study types within a single business line (eg.Chemistry). A GLP/GCP QA Officer III will participate in internal and external facility and supplemental inspections, leads process improvement and harmonization efforts that promote best practices, initiates and reviews SOPs and prepares and delivers training in basic quality/regulatory matters. At this level the individual will be starting to gain experience in assisting with client inspection hosting, and general QMS auditing.
- Performs protocol, data, report, and in-lab phase inspections for all study types within a single business line 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 act as initiator for local SOPs as appropriate
- Participates in internal and external facility and supplemental inspections.
- Prepares and delivers basic quality/regulatory training.
- Leads process improvement and harmonization efforts that promote best practices.
- Gains experience in supporting client visits under supervision *
- Gains experience in conducting QMS audits.
- Performs other related duties as assigned.
Level of education required (or experience level which may be substituted for level of education).
- 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.
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 3.5 years' of experience as a quality auditor in a GxP-regulated environment or 7-10 years experience in a GLP regulated CRO.