QA Specialist (GMP Auditing)

We are currently looking to fill a Quality Assurance Specialist (GMP Auditing) position. This position will support the GMP Auditing department by handling GMP Auditing operational systems, coordinating consultant audit activities and continuous improvement initiatives.

In this role, a typical day might include the following:

• Reviews draft audit reports to identify and evaluate classification of audit observations and finalize into a comprehensive audit report.

• Prepares written audit documents and reports and ensures the quality and accuracy of all audit documentation.

• Identifies and communicates insufficiencies in audit responses.

• Ensures audit issues and extensions are initiated and processed.

• Writes and launches GMP audit CAPAs.

• Prepares and presents metrics to management.

• Assists with onboarding and maintaining GMP Auditing consultant records, assignments and audits.

• Reviews and processes additions and deletions to the GMP Auditing program.

• Supports review of the Audit Master List and audit schedules.

• Supports the internal and external auditors during the conduct of audits.

• Monitors training requirements to ensure department compliance.

• Liaises with audit clients to bring audits to closure.

• Evaluates change notifications received from external suppliers or partners and change controls for impact and ensures corresponding audit requests are submitted.

• Reviews, edits and/or approves controlled documents.

• Ensures written and departmental procedures, timelines and requirements are followed and met.

• Assists with department deviations.

• Assists in regulatory inspections as needed.

• Researches regulatory regulations and presents to GMP Auditing to ensure the department remains current with regulatory changes and trends.

This role may be for you if you:

• Excel in a quality driven organization

• Have knowledge of 21CFR regulations, ICH guidelines, Eudralex, MHRA, EMA, USP, EP and ISO regulations

• Are organized and have an attention to detail

• Can prioritize multiple assignments and changing priorities

• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:

• Associate QA Specialist – 0-2 years

• QA Specialist – 2 years

• Sr QA Specialist – 5 years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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