Quality Assurance Associate - Line Support 2nd shift

About the Company

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. The company has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions, and suppositories, leading to consistent supply to customers and commercialization success. Cosette operates corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

About the Role

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. Act as QA liaison for all Packaging-related events.

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 documentation errors and deviations by proactively responding to situations as they occur.
• Facilitate record corrections to support production and batch release.
• Interact and coordinate with other departments 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.
• Communicate observations effectively to QA and Packaging Management.
• Identify and quarantine non-compliant material.
• Other duties as assigned.

Requirements

• BS Degree in an analytical field of study; or a four-year degree with sufficient credit hours in analytical studies to equal a minor; or five (5) years of applicable experience. Relevant work experience may substitute for the education requirement.
• Relevant experience in a pharmaceutical environment.
• In-depth knowledge of FDA regulations related to plant operations.
• Good problem-solving, organization, documentation, and communication skills.
• Leadership qualities and interpersonal/team-building skills.

Skills

• Good working knowledge of PCs and Microsoft applications, QAD, and Trackwise system.

Schedule

Work hours are 2:00 PM – 10:00 PM, Monday through Friday.

Physical Requirements

• 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.