Curia Supervisor, Quality Control Analytical in Burlington, Massachusetts
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Quality Control Supervisor is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished formulations, and special projects. The supervisor is also responsible for coordinating and performing method development, validation, and transfer activities. This role will oversee the day-to-day functions of their department, and manage a team of Quality Control Chemists.
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.
Manage the Quality Control Team Performance of analytical testing for stability samples and incoming, inprocess and final products
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
Build a sense of customer confidence in departmental results. Will be responsible for providing liaison communication with key members of client organizations
Communicate effectively in both verbal and written form on results, issues and plans. This may involve and include close interactions with customers
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
Organize workloads and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
Manage the performance of QC analytical chemistry assays, HPLC, GC, IR, TOC, Particle Size and wet chemistry assays
Conduct investigations of OOS, Deviations and Change Control Management
Back up for QC analytical instrument maintenance, calibration, and validation
Coordination and performance of QC method qualifications, validations, and transfers
Manage the performance of QC method development and cleaning validation studies
Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure
Authoring and revision of Quality Control SOPs and test procedures
Authoring of validation and transfer protocols and summary reports
Education and Experience
Bachelor’s degree in Chemistry or a scientific discipline with relevant coursework or work experience in analytical chemistry
5+ years’ experience in a GMP or FLP environment, working with HPLC, extensive method development and validation
U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.
Knowledge, Skills & Abilities
Proficient use of computer software, including Microsoft Office Suite (excel, word)
Strong organizational skills with the ability to multi-task
Proficient in HPLC 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
While performing the duties of this job, the employee is regularly required to 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 stand; walk; 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.
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.
All interested applicants must apply online. 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.
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