Job description
Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D.
Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.
Cosette is headquartered in Bridgewater, NJ with 2 additional locations in the U.S. The South Plainfield, NJ office consists of an R&D Laboratory and other functional areas. The Lincolnton, NC site is a fully functioning, state of the art, manufacturing facility.
Innovating every day.™
Basic Purpose:
Manage and coordinate QC laboratory activities to support product filings and launch. Responsible for the review of laboratory monographs, analytical procedures and ensuring that all are current with compendial requirements.
Essential Functions and Responsibilities:
- Works with QC Management and site project manager to identify activities, timing, and resources (human, equipment, and material) in the laboratory necessary for business requirements.
- Write/edit testing monographs for raw materials and finished products.
- Responsible for ensuring laboratory documents are current with all compendial and regulatory specifications.
- Audit method development and special testing data in support of method, process, or instrument validation activities and laboratory/process investigations
- Initiate or write investigations when required.
- Other duties as assigned by QC Management.
Knowledge, Skills, Qualifications and Physical Requirements:
Education/Training/Work Experience:
- Bachelor’s degree with a minimum of five years of industrial experience in one or more of the following areas: project management, administration, marketing, operations, quality, or R&D.
- Demonstrated knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations/requirements.
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.
- Organizational and people skills a must.
- Ability to read and interpret technical documentation, such as Monographs, GTMs, USP/BP Test Methods, Protocols, and FDA Guidance.
Work Environment and Physical Demands:
- Lab coat
- Safety Glasses
- Ability to occasionally lift 50 pounds.
johnandkristie.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, johnandkristie.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, johnandkristie.com is the ideal place to find your next job.