Quality Assurance Specialist - GMP & ISO

Primary Talent Partners; Village of Ardsley (NY); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in life sciences is seeking a Quality Assurance Specialist for a 6-month remote contract. The role involves preparing and managing customer communications related to field actions, ensuring compliance with quality standards and regulations. Ideal candidates will possess strong communication and organizational skills, and have 2-4 years of experience in GMP or ISO quality systems.

Qualifications

• 2 to 4 years of experience in GMP or ISO quality systems in manufacturing.
• Effective communication across departments.
• Proficiency in Microsoft Office is preferred.

Responsibilities

• Prepare customer notification letters for distribution.
• Respond to customer questions and ensure proper tracking of communications.
• Partner with teams to complete objectives related to customer notifications.

Skills

Oral communication

Written communication

Time management

Organizational skills

SOP adherence

Education

GMP or ISO quality systems experience

Tools

Microsoft Office

Job description

Quality Assurance Specialist - GMP & ISO

Primary Talent Partners has a new contract opening for a Quality Assurance Specialist to join our life sciences client. This is a 6-month contract with the potential for extensions. This role is 100% remote, with a preference for candidates in Eastern & Central time zones.

Pay: $45.00/hr - $50.00/hr. W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Top 3 must-haves:

• Oral and written communication skills
• Time management and organizational skills
• Ability to write clear and comprehensive emails to internal resources and external customers

Description:

To prepare field action customer notification letters for distribution to customers and to coordinate all customer communications between the field action teams, quality, customer service, and other departments.

Main Duties:

• Partner with field action teams and global quality to ensure the completion of their objectives
• Write clear and comprehensive emails to internal resources and external customers
• Use customer order information, communication systems, and customer lists to identify contacts and update customer notification lists
• Monitor and reconcile receipt and acknowledgment of customer notifications
• Provide customer notification letters and track responses and acknowledgments
• Respond to customer questions or coordinate responses with technical resources, customer service, quality, and product management
• Ensure proper electronic tracking and storage of information for traceability
• Inform the service organization when a field modification is required and monitor its progress, providing feedback to the field action team monthly
• Provide weekly status updates of assignments

Other Duties:

• Provide data related to the distribution of customer notification letters as needed

Health and Safety:

• Follow relevant legal requirements and company health & safety policies
• Report and address safety defects

Qualifications:

• 2 to 4 years of experience in GMP or ISO quality systems in manufacturing
• Effective communication across departments
• Ability to follow SOPs and work instructions
• Proficiency in Microsoft Office (Excel, Word, Teams, Outlook)
• Strong oral and written communication skills
• Good time management and organizational skills

Primary Talent Partners is an Equal Opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, veteran status, gender identity, or other protected factors.