Quality Assurance Associate - Production Support

Cosette Pharmaceuticals Inc.; Lincolnton (NC); On-site; USD 55,000 - 85,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is a US-based pharmaceutical company providing QA support to Manufacturing & Packaging to ensure finished product compliance with SOPs and GMPs.

The role requires performing checks on batch documentation, releasing products, and quarantining non-compliant material. The candidate should have an Associate degree in analytics or 2+ years of related experience, solid problem solving, documentation, and communication skills, and familiarity with Microsoft applications.

Qualifications

• Associate degree in analytical field or 2+ years related experience.
• Pharmaceutical experience preferred.
• Strong problem solving, organization, and communication skills.
• Proficient with PCs and Microsoft Office applications.

Responsibilities

• Perform 1st and 2nd check on batch documentation per SOPs and GMPs.
• Perform record corrections verification and product release.
• Identify and quarantine non-compliant material.
• Coordinate with Production Support Team and internal/external customers.
• Collaborate with other departments to resolve quality issues and investigate non-compliances.
• Support Packaging and Manufacturing issues; communicate issues to team and supervision.
• Perform QA line support activities including verification and release procedures, end of run reviews, QA checks.
• Approve ProCal reports for metrology.
• Use tracking tools and perform inventory control functions; administer the Deviation system.
• Adhere to internal quality systems and procedures and resolve quality issues.

Skills

Leadership

Interpersonal skills

Team building

Problem solving

Documentation

PC proficiency

Microsoft Office

Education

Associate degree in analytical field

2+ years related experience acceptable

Tools

Microsoft Office

Inventory Control

Veeva

Job 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 1st and 2nd 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.