Supervisor Quality Assurance - Albany, New York
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Quality Control Supervisor is responsible for overseeing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and/or special projects. This role will oversee the day-to-day functions of their department, and manage a team of Quality Control Chemists. This position may require work outside of normal business hours as needed.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.
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
- Learning platform
- And more!
In this role, you will:
- Organize workloads and coordinate activities in order to carry out multiple projects
- Ensure that the stability functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
- Manage and prioritize operations of quality control team(s) supporting Stability testing/reporting Supervise a team but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
- Ensure that operations are conducted in a safe and timely manner. Remain familiar with the contents of the Chemical Hygiene Plan concurrently and in accordance with established objectives, timelines and deadlines.
- Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
- Manage investigations of OOS, deviations and change control management and CAPAs within the QC function
- Supervise and perform pharmaceutical analysis to support drug product/drug substance manufacturing
- Manage client relationships by acting as Quality representative for project meetings.
- Review and approve Stability protocols and reports per ICH guidance.
- Organize workload and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
- Oversee revenue forecasting, interfacing with the sales team, and invoicing for Stability programs
Qualifications and background to be successful in this role:
- Bachelor's degree in Chemistry, Analytical Chemistry, or related field
- Minimum 5 years' experience in a R&D and CDMO Environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation, including a minimum of 3 years supervisory experience
- Strong oral and written communication skills, including effective listening
- Strong organizational skills with the ability to multi-task
- Demonstrated ability to effectively utilize team resources
- Expert in cGMP, USP, EP and FDA regulations
- Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software
- Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment
- Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
Pay Range: $74,000-86,000/ Yr.
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
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