Supervisor, Quality Control

Curia•Springfield, MO

About The Position

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

Requirements

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)

Responsibilities

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.