IT Quality Assurance Director jobs in Frankfort, KY

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?

Come to Adare!

We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients and medicines essential to people all over the world.

Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.

With the help of people like you dedicated to our mission, Adare is

Adare !What can Adare offer you?Medical / dental / vision / life low employee premiums401k with a highly competitive matchGenerous PTO, including floating holidaysCareer growth and internal opportunitiesTuition reimbursementRelocation assistancePerformance-based bonusEmployee Recognition ProgramsWe are seeking to hire a

Quality Assurance Technician

to join our

Quality Assurance Team If any of the below describes you, we would love to meet you!JOB SUMMARYThe QA Technician is responsible for providing quality support to the manufacturing floor, auditing batch production documentation, dispositioning intermediates and equipment after cleaning, performing in process checks, reviewing and approving incident reports, revise quality documents (e.

g. SOP, protocols, methods), and ensuring adherence to cGMP.ESSENTIAL DUTIES AND RESPONSIBILITIES : Production Support : Partner with Operations employees to document incidents, and resolve other outstanding plant quality / compliance issues.

Provide Quality support on the manufacturing shop floor.Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements.

Collect cleaning samples.Disposition equipment after cleaning.Disposition Product : Perform in-process tests as required by the batch record / SOPReview executed Production Records, Packaging Records and Analytical results for compliance to established internal procedures, methods, specifications and industry standards.

Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.Conduct product release activities for intermediates.

Investigations : Work with Quality Assurance Specialists to determine if incidents need further investigation / escalation.

Projects : Participates on project teams as assigned by management.Propose and author departmental procedures changes consistent with objectives of simplification and process efficiencies / improvements which ensure ongoing compliance.

Completes all assigned training by target due dates.Files GMP documentation.Interface with all departments within the company.

Be an ambassador for Quality within the company.Maintain professional interactions with all departments and other sites.Ensure facility adherence to cGMP.

Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.

Follow other job-related instructions and perform other tasks as required.Attends work on a regular and predictable basis.

Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.

Perform other tasks as required.Bachelor’s Degree required preferably in a related field (i.e. pharmaceutical sciences, chemistry, biology)0-2 years of experience in the pharmaceutical industryKnowledge in cGMP as related to records and documentation in a pharmaceutical manufacturing environment preferredAccuracy and neatness of compiling documents are required.

Good oral and written communication skills.Medical / dental / vision / life low employee premiums401k with a highly competitive matchGenerous PTO, including floating holidaysCareer growth and internal opportunitiesTuition reimbursementRelocation assistancePerformance-based bonusEmployee Recognition Programs

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Last updated : 2024-04-07