Sr. QA Product Complaint Investigator-REMOTE

Judge Group

(remote)

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JOB DETAILS

SALARY

$50–$70 Per Year

SKILLS

Biotech and Pharmaceutical, Call Centers, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Customer/Client Research, Data Collection, Distribution Services, Document Management, Identify Issues, Logistics, Maintain Compliance, Presentation/Verbal Skills, Process Development, Process Manufacturing, Quality Assurance, Quality Control, Regulatory Requirements, Risk, Root Cause Analysis, Short Messaging Service (SMS), Systems Maintenance, Time Management

POSTED

10 days ago

Location: REMOTE
Salary: $50.00 USD Hourly - $70.00 USD Hourly
Description: Our client is currently seeking a Sr. QA Product Complaint Investigator-REMOTE
Triage incoming
complaints and engage with call center as necessary
Initiate customer complaints, investigations, and
supplier corrective action requests
Manage and document
thorough and accurate complaint records while ensuring they are processed
in a uniform and timely manner.
Ensure complaint records
and applicable complaint handling documents are compliant with Good
Documentation Practices (GDP).
Follow-up with
complainants to gather information required for robust complaint handling
activities
Maintain professional
communications with internal and external customers to gain insight into
each complaint event and product sample return.
Facilitate complaint
product returns utilizing the Moderna logistics program and engaging with
the logistics team.
Ensure appropriate root cause analysis is completed by
contract partners and subject matter experts
Monitor compliant investigation CAPA’s, ensure
effectiveness and adherence to commitments
Review and prepare
customer communication (response letters, acknowledgement letters)
Will be responsible for initiating product complaints and conduct compliant investigations from start to completion.

Job Duties:
• Create and maintain data tracking systems that govern the complaint program.
• Initiate complaints and manage compliant investigations from start to completion.
• Review and approve complaint investigations and ensure compliance with internal policies/procedures and regulatory requirements and guidance.
• Maintain complaint data, review data for trends and ensure high risk / systemic issues are identified and escalated promptly
• Monitor compliant investigation CAPA's, ensure effectiveness and adherence to timelines / customer commitments.
Job Qualifications:
• 5+ years of Quality/Product Investigation experience in biotech or pharmaceutical industry Required.
• Demonstrated skill in facilitating complex investigations from initiation to completion.
Must have strong investigation skills
• Knowledge of Root Cause Analysis (RCA) process.

• Experience working on Supplier Corrective Action Reports (SCAR)Preferred
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development.
• Excellent communication and executive presence (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.

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Contact: psalvatore@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

About the Company

Judge Group

The Judge Group Inc., is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better. Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India.

The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications. If you would like to learn more about The Judge Group visit www.judge.com or call toll free (800) 360-4474.

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Computer/IT Services

FOUNDED

1970

WEBSITE

https://www.judge.com