Massachusetts Jobs

quality systems specialist complaints.

• north billerica , massachusetts

• posted 2 days ago

job details

summary

• $50 - $58 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48403

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: North Billerica, Massachusetts

job type: Contract

salary: $50 - 58 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

Responsible for investigating Product Quality Complaints, coordinating the Annual Product Quality Reports (APQR), and Metrics Reporting. Other functional responsibilities may include authoring and revising Quality System Documentation and trending and evaluating Product Quality.

• Initiates product quality complaints in our Quality Management System (QMS).

• Performs product quality complaint investigations and assigns investigation tasks to technical functions as needed.

• Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.

• Evaluates scientific data for trends, drives investigations, and proposes the need for changes to manufacturing or control procedures.

• Documents complaint investigation activities and summary. Responsible for timely closure of complaints.

• Recommends the need for further investigation and escalation to CAPA. Drives closure of associated investigation(s) and CAPA(s).

• Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.

• Responsible for Annual Product Quality Reports (APQR). Collaborates with internal stakeholders on data collection and ensures timely completion of reports.

• Responsible for collecting and reporting metrics as required per internal procedures and as requested by leadership.

• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.

• Actively demonstrates values.

• Other duties as assigned.

qualifications:

• Bachelor of Science in a technical discipline or equivalent combination of education and experience.

• Minimum of 5 years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.

• Experienced in investigating and documenting Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.

• Experienced with metrics reporting.

• Organized, detail oriented and self-motivated.

• Exposure to Annual Product Quality Reviews preferred.

skills: Quality Assurance, CAPA

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 HRsupport@randstadusa.com.

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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.