Quality Assurance Specialist - GMP & ISO

Primary Talent Partners; Village of Ardsley (NY); Remote; USD 80,000 - 100,000; Part 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 customer notification letters, ensuring effective communication, and maintaining traceability of actions within the quality assurance framework. Ideal candidates will possess strong communication skills and have experience in GMP or ISO environments.

Qualifications

• 2-4 years experience in GMP or ISO quality system manufacturing environment.
• Ability to communicate effectively across departments.
• Ability to follow standard operating procedures.

Responsibilities

• Prepare customer notification letters and coordinate communications.
• Monitor and reconcile customer notification.
• Provide status updates of assignments on a weekly basis.

Skills

Oral communication

Written communication

Time management

Organizational skills

Tools

Microsoft Excel

Microsoft Word

Microsoft Teams

Microsoft Outlook

Job description

Quality Assurance Specialist - GMP & ISO

Quality Assurance Specialist - GMP & ISO

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Primary Talent Partners provided pay range

This range is provided by Primary Talent Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $50.00/hr

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
• 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, service, etc.

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, customer communication system, and customer list to identify contacts, email addresses, street addresses, etc., to update CNL with customer-specific information
• Monitor and reconcile CNL receipt and or acknowledgement
• Provide customer notification letters to customers and track customer responses and acknowledgements
• Respond to customer questions or coordinate the response with technical resources, customer service, quality, and product management as necessary
• Ensure proper electronic tracking and storage of information for traceability
• Inform the service organization when a field modification is required and monitors progress of that field modification to provide feedback to the field action team on a monthly basis.
• Provide status updates of assignments on a weekly basis, at a minimum.

Other Duties:

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

General Health and Safety:

• To follow relevant legal requirements and the Company Health & Safety Policy.
• Report and address any safety defects.

Qualifications:

• Two (2) to four (4) year’s experience in GMP or ISO quality system manufacturing environment
• Ability to communicate effectively across all departments and functions
• Ability to follow standard operating procedures, work instructions, and other applicable documents
• Able to use Microsoft products such as Excel, Word, Teams, and Outlook
• Oral and written communication skills
• Time management and organizational skills
  
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Staffing and Recruiting

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