QA Operations Specialist

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

The QA Operations Specialist (Level 1) is responsible for quality oversight and guidance for Azurity Pharmaceuticals manufacturing facility. The QA Operations Specialist (Level 1) will be a key member of QA Ops team and is responsible for supporting the Manufacturing team by ensuring components, equipment and documentation are cleared for the manufacturing. In addition, he/she will be responsible for ensuring Azurity Pharmaceutical’s quality policies, practices, procedures, standards, and systems for necessary adherence to production and product management in accordance to the cGMP compliance to US regulations are being maintained.

Principle Responsibilities:

• Support manufacturing operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
• Generate expiration dates for in-house products.
• Perform pre and post line clearance inspections.
• Perform in-process inspection of work-in-process product.
• Perform AQL inspection of finished goods.
• Review and approve documents including: Manufacturing batch records in support of product release.
• Support a state of continuous inspection readiness.
• Participate in the QA walk through program.
• Oversee quality support for powder and liquid fill operations.
• Work directly with Production and Engineering on qualification and validation activities.
• Build cross functional relationships with Production, Engineering, Quality Control, and Supply Chain.
• Additional QA support activities for establishing GMP facility and manufacturing operations.
• May require to perform other tasks/projects as needed.

Qualifications and Education Requirements

• Associate’s degree or Bachelor’s degree with working experience.
• 3+ years of industry QA line inspection or manufacturing experience.
• Good interpersonal communication skills/able to work in a team environment.
• Detail oriented with ability to detect and articulate nonconforming issues.
• Knowledge and understanding of cGMP regulations
• Have a sense of urgency and attention to detail.
• Have a sense of customer service when interacting with other Azurity functional groups.
• Ability to take daily instructions from QA Operations Supervisor and carry out instructions.
• Ability to stand and walk 80% of the time.
• While performing the duties of this job, the employee is frequently required to walk, talk and/or hear. The employee is occasionally required to stand, sit and use hands to finger, handle or feel.
• The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include: close vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• This position requires significant amount of time in the Operations area.
• Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.

Physical & Mental Requirements:

The physical demands described her