Quality Assurance Associate - Line Support (2Nd/3Rd Split Shift)

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:
Perform QA line verifications prior to the start of every packaging lot. Monitor Packaging operations along with all associated documentation (records, cleaning tickets, logbooks, etc.) Support operations by reviewing and approving notations to documents at time of generation. Perform record review as a supplemental function. Act as QA liaison for all Packaging related events.
Essential Functions and Responsibilities:
• Review in-process and completed documentation.
• Review and approve notations to in-process and completed documents.
• Perform QA Line Verifications prior to line release in Packaging.
• Interact closely with Packaging to minimize # of documentation errors and       Deviations by proactively responding to situation as they occur.
• Facilitate record corrections to support production and batch release.
• Interact and coordinate with other departments as necessary to successfully complete job tasks and assist with resolution of issues.
• Adhere to and enforce internal quality systems and procedures.
• Utilize knowledge of SOPs and GMPs to resolve quality issues.
• Interact positively within Production Support Team and Packaging departments.
• Communicate observations to QA and Packaging Management effectively.
• Identify and quarantine non-compliant material.
• Other duties as assigned.
Knowledge, Skills, Qualifications and Physical Requirements:

Education/Training/Work Experience:
• BS Degree in analytical field of study; or four-year degree with sufficient credit hours in analytical studies to equal a minor degree; or five (5) years of applicable experience.
• Relevant work experience may be considered as a substitute for education requirement.
Specialized Knowledge and Skills:
• Relevant experience in pharmaceutical environment.
• Leadership qualities, interpersonal and team building skills.
• In-depth knowledge of FDA regulations related to plant operations.
• Good problem solving, organization, documentation and communication skills.
• Ability to perform essential functions as listed above.
Equipment and Applications:
• Good working knowledge of PCs and Microsoft applications, QAD, and Trackwise system.
Work Environment and Physical Demands:
• Ability to occasionally lift 50 pounds.
• Ability to stand for extended periods of time.
• Ability to sit at a workstation for extended periods of time.