Associate – 3rd Party Quality Operations

Cosette Pharmaceuticals, Inc.

Quality Assurance Associate managing third-party quality operations for COSSETTE Pharmaceuticals. Responsible for quality oversight activities and documentation compliance with regulatory requirements in quality systems.

Posted 7/27/2026full-timeLincolnton • North Carolina • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP Documentation, Quality Systems, and Regulatory Requirements, with a strong focus on maintaining compliance and supporting continuous improvement initiatives. Proficient in managing technical documentation and collaborating with internal and external stakeholders to ensure product quality and adherence to industry standards.

Highest-signal resume keywords

GMP DocumentationQuality SystemsRegulatory RequirementsElectronic Quality Management SystemsTechnical Document Review

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GMP DocumentationQuality SystemsRegulatory RequirementsTechnical Document ReviewQuality System ProcessesProblem-SolvingCritical ThinkingPharmaceutical ManufacturingContinuous ImprovementAttention to Detail

Soft Skills

Organizational SkillsEffective CommunicationCustomer-Service MindsetCollaborationAbility to Manage Multiple Priorities

Tools & Technologies

Microsoft OfficeElectronic Quality Management SystemsVeeva

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceRegulated IndustryCGMP Regulations

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
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.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible working hours
Paid time off