Quality Assurance Specialist Job Cambridge area,Massachusetts USA,Quality Assurance

The Role

The individual in this role will be responsible for providing Quality Assurance (QA) support for Customer Complaint Management program. The individual will primarily work with customers, Commercial Operations, Technical Development, Regulatory Affairs and MS&T to support the complaint management program for company. This individual will support quality systems and governance, initiate complaints, initiate, and manage compliant investigations and drive continuous GMP improvement in the complaint management process.

Additionally, the individual may be asked to create and maintain data tracking systems that govern the compliant management program.

contract position
Pay $50 to $55 an hour

Here’s What You’ll Do

Initiate customer complaints and compliant investigations
Provide an effective level of support (troubleshooting) to customer facing teams, subsidiaries, wholesalers, distributors, and others as required.
Manage and review complaint investigations from various stakeholders.
Ensure appropriate root cause analysis is performed by subject matter experts.
Monitor compliant metrics to ensure complaints are leveled and investigated appropriately.
Maintain complaint data, review data for trends and ensure high risk / systemic issues are identified and escalated promptly.
Monitor compliant investigation CAPAs, ensure effectiveness and adherence to timelines, health authority and customer commitments.
Report compliant investigation outcomes to customers as requested.
Monitor customer satisfaction and feedback as necessary.
Lead cross functional meetings related to complaints.
Support escalations, market actions and inquiries as requested.
Manage projects as they are assigned by leadership.

Here’s What You’ll Need (Basic Qualifications)

Bachelor’s degree in a life science or engineering discipline
Minimum 2-5 years’ experience within the biotechnology, medical device, or pharmaceutical industry.
Ability to write technical investigation summaries for multiple audiences.
Excellent communication skills, both written and verbal.
Problem solving skills
Highly organized with strong attention to detail
Self-motivated
Proficient in MS Word, Excel, Visio, and Power Point
Ability to prioritize workload and effective time management.

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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