Associate, 3rd Party Quality Operations-1st Shift

cosettepharma; Lincolnton (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. in the United States seeks a Quality Assurance Associate to support 3rd party quality operations, maintaining quality documentation and overseeing customer complaints. The role involves reviewing GMP documents, assisting with investigations, and ensuring compliance with regulatory requirements.

Compensation will align with education and experience. Associate level placement will be determined based on education, industry experience, and demonstrated competencies,

Qualifications

• Bachelor's degree in a scientific discipline preferred.
• Associate degree may be considered with relevant industry experience.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated industry preferred.
• Experience with GMP documentation, quality systems, and regulatory requirements is preferred.
• Strong organizational, communication, and technical document review skills.

Responsibilities

• Administer customer complaints within the applicable quality systems.
• Assist with review of batch records, investigations, specifications, complaint reports, and other GMP documentation from third-party manufacturers.
• Maintain supplier and contract manufacturer quality documentation files.
• Coordinate documentation requests with third-party manufacturers and internal stakeholders.
• Maintain accurate records in accordance with company procedures and regulatory requirements.
• Support continuous improvement initiatives and quality system compliance activities.
• Perform other duties as assigned.

Skills

Organizational skills

Communication

Document review

cGMP knowledge

Attention to detail

Problem solving

Time management

Education

Bachelor's degree in science

Associate degree with experience

Tools

Microsoft Office

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

The Quality Assurance Associate, 3rd Party Quality Operations, supports quality oversight activities for products manufactured by third-party contract manufacturers.

The Associate is responsible for maintaining quality documentation, administering customer complaints, supporting document review activities, and assisting with quality metrics reporting to ensure compliance with company procedures and applicable regulatory requirements.

Associate level placement will be determined based on the candidate's education, relevant industry experience, technical knowledge, and demonstrated competencies. Compensation will be aligned with the candidate's qualifications and experience.

Essential Functions and Responsibilities

• Administer customer complaints within the applicable quality systems.
• Assist with review of batch records, investigations, specifications, complaint reports, and other GMP documentation received from third-party manufacturers.
• Maintain supplier and contract manufacturer quality documentation files.
• Coordinate documentation requests with third-party manufacturers and internal stakeholders.
• Maintain accurate records in accordance with company procedures and regulatory requirements.
• Support continuous improvement initiatives and quality system compliance activities.
• Perform 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

• Bachelor's degree in a scientific discipline preferred.
• Associate degree may be considered in combination with relevant industry experience.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated industry preferred.
• Experience with GMP documentation, quality systems, and regulatory requirements is preferred.
• Strong organizational, communication, and technical document review skills.
• Associate level placement will be determined based on the candidate's education, relevant industry experience, technical knowledge, and demonstrated competencies.
• Compensation and level within the Associate job family will be aligned with the candidate's qualifications and experience.

Specialized Knowledge and Skills

• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills.
• Ability to review technical documentation with training and guidance.
• Familiarity with cGMP regulations and quality systems preferred.
• Proficiency with Microsoft Office applications.
• Ability to manage multiple priorities and meet deadlines.
• Ability to work independently while appropriately escalating issues.
• Experience with electronic quality management systems such as Veeva preferred.
• Working knowledge of quality system processes including complaints, deviations, investigations, and document management preferred.
• Ability to interpret and apply company procedures, quality standards, and regulatory requirements.
• Strong problem-solving and critical-thinking skills with the ability to identify and communicate potential compliance risks.
• Demonstrated ability to collaborate effectively with internal stakeholders and external business partners.
• Ability to learn and apply technical concepts related to pharmaceutical manufacturing, product quality, and regulatory compliance.
• Strong customer-service mindset with the ability to maintain professional relationships with third-party manufacturers and suppliers.
• Demonstrated commitment to quality, accuracy, and continuous improvement.

Equipment and Applications

• Microsoft applications and Veeva preferred.