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.

We proudly offer

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

Essential job duties

• 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

Quality Expectations of this Position:

• 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.

Education, experience, certification and licensures

Required

• 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

Knowledge, skills and abilities

• 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);

Physical requirements

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk; and sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

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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