Metrologist

Cosette Pharmaceuticals Inc. • Lincolnton, NC

2d

About The Position

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:
The Metrologist will be responsible for qualifying, maintaining, troubleshooting, and repairing laboratory or manufacturing operations instruments and equipment.

Requirements

• BA/BS in Chemistry, Engineering, or other related discipline or a minimum of 7 years of relevant experience in the Pharmaceutical industry.
• Minimum of 2 years’ experience with equipment maintenance, calibration, and documentation of this equipment.
• Demonstrated analytical and problem-solving skills.
• Demonstrated ability to multi-task and work successfully in a team environment.
• Knowledge of cGMPs, GDPs, OSHA, and 21 CFR 11 requirements.
• Good written and oral communication skills.
• Technical writing and review.
• Computer skills, including software interface with equipment/instrumentation.
• Working knowledge of analytical instruments used in quality control (ie. – HPLC, GC, FTIR, etc.) or instruments used in the manufacturing operations (ie. – Becomix, CIP conductivity Skids, HMI, etc.).
• Able to conduct and lead investigations related to troubleshooting and problem solving of instruments, equipment, and methods.

Responsibilities

• Performs preventative, routine, and other necessary maintenance on instruments and equipment to support lab or manufacturing operations.
• Writes, reviews, and executes equipment Installation, Operational, and Performance Qualification Protocols for new and existing equipment.
• Track and coordinate outside vendor service contracts for equipment maintenance.
• Track and coordinate the sending out of equipment for vendor calibration/repair.
• Supports QC or manufacturing operations by troubleshooting instrument/equipment performance issues, performing minor repairs, and training operators as necessary.
• Other duties as assigned by management

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level