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 and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that 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 team…
If any of the below describes you, we would love to meet you!

JOB SUMMARY
This position 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, reviewing finished product records, revise quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES
• Partner with Operations employees to document incidents, and resolve other outstanding plant quality/compliance issues.
• Provide Quality support on the manufacturing shop floor.
• Escalate issues found during walkthroughs to management.
• 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.
• Audits production logbooks
• Disposition equipment after cleaning.
• Review executed Production Records (Intermediate and Finished), , 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.
• Identify incidents, log events, and notify affected departments of the incidents
• Review and close incident reports.
• Determine if incidents need further investigation/escalation.
• Enter investigations into access database.
• 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.
• Train QA Technician I and II as assigned
• 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.

REQUIRED SKILLS AND QUALIFICATIONS
• Associates Degree preferred in a related field (i.e. pharmaceutical sciences, chemistry, biology) with 3+ years of experience in the pharmaceutical or other regulated industry.
• Knowledge in cGMP as related to records and documentation in a pharmaceutical manufacturing environment preferred
• Auditing experience required.
• Accuracy and neatness of compiling documents are required.
• Good oral and written communication skills.

PHYSICAL REQUIREMENTS:
The employee is required to stand, walk, push, pull, twist, reach overhead, and bend to the floor, have visual sharpness for reading written instructions and computer screen, and is subject to office, production and warehouse environments.

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