Quality Assurance Associate - Line Support 2nd shift
Cosette Pharmaceuticals, Inc., Lincolnton, NC, United States
Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. The company has a fast-growing portfolio of branded pharmaceuticals in cardiology, women's health, and migraine markets. Its facilities are located in New Jersey and North Carolina and are supported by more than 300 dedicated employees.
Basic Purpose
Perform QA line verifications prior to the start of every packaging lot. Monitor Packaging operations and 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.
Work Hours
2:00pm - 10:00pm (Monday - Friday)
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 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 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 an 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 the education requirement.
Specialized Knowledge and Skills
Relevant experience in a 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.
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, affectionate 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.
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Basic Purpose
Perform QA line verifications prior to the start of every packaging lot. Monitor Packaging operations and 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.
Work Hours
2:00pm - 10:00pm (Monday - Friday)
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 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 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 an 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 the education requirement.
Specialized Knowledge and Skills
Relevant experience in a 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.
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, affectionate 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.
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