Quality Assurance Associate - Production Support

Cosette Pharmaceuticals, Inc.; Lincolnton (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is seeking a QA support specialist to ensure finished products comply with GMPs through review of batch documentation and QA checks in Manufacturing and Packaging.

You will perform checks, identify non-conformities, and coordinate with Production Support and other departments to resolve quality issues. The position requires an eye for detail, strong documentation skills, and the ability to work independently as well as part of a cross-functional team in a dynamic

Qualifications

• Associates degree in analytical field or 2+ years of applicable experience.
• Experience in pharmaceutical environment preferred.
• Strong documentation and compliance capabilities.

Responsibilities

• Perform 1st and 2nd check on batch documentation.
• Identify and quarantine non-compliant material.
• Support QA line and release procedures.
• Coordinate with departments to resolve quality issues.
• Use QA tracking tools and databases for records.

Skills

Leadership

Interpersonal skills

Team building

Problem solving

Documentation

MS Office

Education

Associates Degree in analytical field

2+ years of experience

Tools

Veeva

Inventory Control

Microsoft Applications

Job description

Description

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.

Description

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:

Provide QA support to Manufacturing & Packaging. Ensure finished product complies with all regulatory requirements through review of batch documentation in accordance with appropriate SOPs and GMPs. Ability to perform listed tasks independently.

Essential Functions and Responsibilities:

• Perform 1 st and 2 nd check on completed batch documentation per applicable SOPs and GMPs.
• Perform record correction verification and product release.
• Identify and quarantine non-compliant material.
• Interact positively within Production Support Team, and internal / external customers.
• Interact and co-ordinate with other departments as necessary to complete QA tasks successfully; assists with resolution of issues providing feedback on investigation of non-compliant situations.
• Support Packaging and Manufacturing issues. Utilize knowledge of SOPs and GMPs to resolve quality issues. Communicate details of issues to team members and supervision.
• Perform QA Line Support activities including verification and release procedures, end of run reviews, QA checks.
• Ability to approve ProCal reports for metrology.
• Use departmental tracking tools (i.e., databases, etc.). Perform necessary Inventory Control functions (release, quarantine, etc.). Administer the Deviation system.
• Adhere to and enforce internal quality systems and procedures. Utilize knowledge of SOPs and GMPs to resolve quality issues.
• Other duties as assigned.

Knowledge, Skills, Qualifications and Physical Requirements:

The following describes the general knowledge, skills, qualifications, and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.

Education/Training/Work Experience:

• Associates Degree in analytical field of study or two (2) plus 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.
• Good problem solving, organization, documentation and communication skills.
• Good working knowledge of PCs and Microsoft applications.

Equipment and Applications:

• Microsoft Applications, Inventory Control , and Veeva

Work Environment and Physical Demands (List required PPE’s):

• Ability to occasionally lift 50 pounds.
• 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, affectional 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.