Description
Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.
Innovating every day.™
Basic Purpose:
Supervise QC analysts and/or lab assistants to perform testing to support all quality analyses for finished products and other required samples.
Essential Functions and Responsibilities:
Maintain and supervise sufficient headcount to meet the testing demands of supporting production, validation, stability, and other projects for the site
Manage cycle times to ensure timely completion of all testing and ensure that testing is completed in full compliance with cGMPs and 21 CFR; provide communication with other departments to optimize production and release schedules
Conduct laboratory investigations to address Out of Specification (OOS), Out of Alert (OOA), or Out of Trend (OOT) results
Provide training and technical support to QC staff for instrumentation, analyses, validation studies, etc.; ensure training documentation is current and that staff is making appropriate progress in training curricula
Participate in interviewing and selection of potential QC staff
Provide coaching to staff, prepare and deliver performance reviews, prepare and deliver corrective actions when warranted
Other duties as assigned by QC Manager.
Knowledge, Skills, Qualifications and Physical Requirements:
Education/Training/Work Experience:
BA/BS in Chemistry, Microbiology, or related scientific field and five years of directly related lab experience in a GMP regulated industry
Previous supervisory experience
Demonstrate knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations/requirements
Demonstrate ability to manage high volume testing and meet established deadlines
Demonstrate knowledge of technical aspects of laboratory including instrumentation troubleshooting, validations, and calibration of equipment
Specialized Knowledge and Skills:
Project management, oral and written communication, and leadership skills
Proficient in technical writing
Ability to multi-task under stress of multiple priorities
Detailed understanding of general chemistry and/or microbiology principles
Good organizational and people skills
Equipment and Applications:
Trackwise
Access
Work Environment and Physical Demands (List required PPE's):
Lab coat
Safety glasses
Ability to occasionally lift up to 50 pounds.
Equal Opportunity Employment
Providing "equal employment opportunity" is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.
