Supervisor, Quality Control

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

• Generous benefit options
• Paid training, vacation and holidays
• Career advancement opportunities
• Education reimbursement
• 401k program
• And more!

• Manage the Quality Control Team Performance of analytical testing for various samples and incoming, in process, final products, and stability
• Ensure that the analytical chemistry functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
• Supervise a team of scientists including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
• Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
• Communicate effectively in both verbal and written form on results, issues and plans. This may involve and include close interactions with other departments and/or customers
• Organize workloads and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
• Assist with the maintenance, calibration, and validation of QC lab analytical instrumentation
• Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs
• Supervise and perform pharmaceutical analysis to support API manufacturing
• Authoring and revision of Quality Control SOPs and test procedures

• Perform all documentation in compliance with good documentation practices as defined by site SOP’s.
• Strict compliance with all cGMP document SOP’s, Batch records, protocols, Change controls, controlled forms
• Ensure all cGMP applicable training is kept current
• Oversee and monitor performance of staff to ensure compliance with all cGMP SOP’s.
• Provide training and guidance to staff as needed on site SOP’s, Batch records, protocols, change controls, controlled forms, etc.
• Ensure staff have appropriate training documented prior to assigning work
• Escalate any quality concerns to quality department.

• Bachelor’s degree in Chemistry or a scientific discipline with relevant coursework or work experience in analytical chemistry
• Minimum 5 years’ experience in a GMP or GLP environment working with Chromatography (HPLC/UPLC/GC), and other common analytical instrumentation

• Ability to recognize what needs to be done, take action, and accomplish results
• Strong oral and written communication skills, including effective listening
• Demonstrated ability to effectively utilize team resources
• Expert in cGMP, USP, EP and FDA regulations
• Technical competence including the understanding of theory and interpretation of all lab techniques
• Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software
• Strong organizational skills with the ability to multi‑task
• Proficient in HPLC and GC operation with experience with multiple other analytical techniques and analytical equipment
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600);

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.…