3Rd Shift Quality Assurance Technician-Dungan Rd

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 transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

We 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 SUMMARY

The 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.
• Issue batch production and cleaning records.
• Disposition equipment after cleaning.

Disposition Product:

• Review 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:

• Review incident reports to insure they are properly documented.
• Work with Quality Assurance Specialists to determine if incidents need further investigation/escalation.
• Enter investigations into access database.

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.

Requirements

• Bachelor’s Degree required preferably in a related field (i.e. pharmaceutical sciences, chemistry, biology)
• 0-2 years of experience in the pharmaceutical industry
• Knowledge in cGMP as related to records and documentation in a pharmaceutical manufacturing environment preferred
• Accuracy and neatness of compiling documents are required.
• Good oral and written communication skills.

Benefits

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES