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 Specialist to join our Quality Assurance Team …

If any of the below describes you, we would love to meet you!

JOB SUMMARY

This position is responsible for the audit of batch production documentation (manufacturing records, analytical records, deviation investigations), Development support, Contract Manufacturing oversight, disposition of product, approving quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Audit Analytical testing and executed Batch Production Records.
• Review and approve Deviations and Lab Investigations.
• Coordinate and support Quality Assurance aspects of Product Development and Contract Manufacturing activities.
• Perform cleaning verification visuals and swabs.
• Release in-process materials for further processing and finished products for shipment.
• Interact with Customer’s Quality associates as necessary.
• Maintain and assure correctness of documentation.
• Interface with all departments within the company.
• Ensure facility adherence to cGMP.
• Maintain the confidentiality of pertinent information.
• 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.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
• Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.
• Works effectively under deadlines.
• Perform other tasks as required.

REQUIRED SKILLS AND QUALIFICATIONS

• Bachelor’s Degree preferred, with at least 2-6 years of Quality experience in a pharmaceutical or similarly regulated industry.
• Experience using a Quality Management System; experience with Veeva preferred.
• Experience with using the Microsoft Office Suite of software (Word, Excel, PowerPoint) is preferred.
• Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment is preferred.
• Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation systems is highly preferred.
• Accuracy and neatness of compiling documents.
• Attention to detail.

PHYSICAL REQUIREMENTS

• Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
• Occasionally move items or equipment weighing up to 40 pounds – potential to handle heavier materials with mechanical assistance.
• Occasionally required to climb ladders and/or steps to reach equipment.

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