Quality Assurance Specialist Ii

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?

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

We are seeking to hire a Quality Assurance Specialist II 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

• Release in-process materials for further processing and finished products for shipment.
• Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.
• Interface with all departments within the company.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Follow other job-related instructions and perform other tasks as required.
• Audit Analytical testing and executed Batch Production Records.
• Ensure facility adherence to cGMP.
• Perform other tasks as required.
• Maintain and assure correctness of documentation.
• Works effectively under deadlines.
• Maintain the confidentiality of pertinent information.
• Review and approve Non-Conformance Investigations (IR, NCIR, LIR, OOS).
• Attends work on a regular and predictable basis.
• Interact with Customer’s Quality associates as necessary.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
• Coordinate and support Quality Assurance aspects of Product Development and Contract Manufacturing activities.
• Perform cleaning verification visuals and swabs.
• Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.

Requirements

• Attention to detail.
• Bachelor’s Degree preferred, with at least 4-6 years of Quality experience in a pharmaceutical or similarly regulated industry.
• Accuracy and neatness of compiling documents.
• 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.
• Experience using a Quality Management System; experience with Veeva preferred.

Physical Requirements

• Occasionally move items or equipment weighing up to 100 pounds – potential to handle heavier materials with mechanical assistance.
• Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
• Reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
• Occasionally required to climb ladders and/or steps to reach equipment.

Benefits

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