Manager, Quality Assurance

Curia • Albany, NY

2d

About The Position

Build your future at Curia, where our work has the power to save lives. The Quality Assurance Manager is responsible for oversight of the conditions and activities in the aseptic environment of the manufacturing areas to ensure continual compliance with cGMP. This position requires expertise in all aspects of aseptic manufacturing of sterile product, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing environment and will report metrics to site management on a regular basis. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. We proudly offer Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more!

Requirements

• Bachelor’s Degree in Microbiology, Chemistry or related field
• Minimum 5 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years’ supervisory experience, OR Master’s Degree in Microbiology, Chemistry or related field with minimum 3 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years’ supervisory experience
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Advanced degree in related field
• Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications

Responsibilities

• Assist the Director, QA with the development, implementation, and strict adherence to the quality assurance program
• Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials
• Oversee and assist with the site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications
• Ensure immediate action is taken when non-compliance and/or undesired behavior by personnel in the facility is observed
• Make recommendations regarding facilities, equipment, personnel, procedures, and systems to carry out the quality function
• Ensure that the data integrity principles are understood and implemented consistently throughout the site
• Lead process improvement program including collaboration with Operations, Quality, and/ or Training Leadership to make recommendations for enhancements to quality processes, teaching/coaching, and implementation of procedures
• Coordinate corrective action training based on both immediate and long-term feedback gathered from observations and evaluations
• Assist Director, QA during inspections by regulatory authorities, including implementing inspection-readiness programs and ensuring that proper CAPAs are prepared and completed on time
• Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong, site-wide quality culture while achieving the site business goals. This includes also leading and supporting site-wide cGMP training activities
• Communicate effectively with internal and external customers making sure that the Curia values and business goals are consistently achieved
• Ensure daily inspections are being carried out

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees