This contract role for a Senior Quality Systems Specialist offers a dynamic opportunity for a seasoned professional with a strong background in quality and manufacturing within the pharmaceutical, medical device, or biological industries. The ideal candidate will be adept at performing internal and external audits, creating and revising quality system documentation, and expertly managing product quality complaints from initiation through investigation and closure. This position demands a proactive approach to compliance, a keen eye for detail in data analysis, and excellent collaboration and communication skills to drive continuous improvement within a cGMP-compliant environment.
location: North Billerica, Massachusetts
job type: Contract
salary: $50 - 60 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Perform internal audits and other inspection walkthroughs, as well as reviewing documents for compliance to regulatory guidelines and internal process requirements.
- Support external audits through back-room audit support.
- Create new and/or revise existing quality system documentation.
- Develop and support quality metrics initiatives.
- Initiate complaints within the Quality Management System (QMS)
- Perform Product Quality Complaint Investigations and drives closure of associated CAPA(s).
- Collaborate with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
- Perform routine trending of product complaints and evaluates trends, escalating issues as necessary.
- Evaluate scientific data for trends, drives Investigations, and proposes the need for changes to manufacturing or control procedures.
- Support writing and approval cycle for Annual Product Quality Reports (APQR). Manages the development of less complex APQRs, collaborating with internal stakeholders.
- Foster an environment that drives continual improvement, and champions a quality culture throughout the organization.
- Actively promotes safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
- Other duties as assigned.
qualifications:
Required:
- Bachelor of Science in a technical discipline or equivalent combination of education and experience.
- Minimum of five (5) years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.
- Demonstrated knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.
- Proficient in conducting GMP compliance audits in a pharmaceutical GMP compliance organization.
- Experienced in investigating Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
- Experience working with electronic eDMS platforms.
- Good planning and project management skills.
- Solid verbal, written and presentation skills at all levels both internally and externally.
- Must be detail oriented with the ability to multitask and respond to ever changing priorities.
- Organized and self-motivated.
- Ability to work independently and drive on time completion of responsibilities and assigned tasks.
- Own the solution and make it happen.
- Previous TrackWise experience
- Exposure to Annual Product Quality Reviews.
skills: ICH Regulations, GMP (Good Manufacturing Practice), Quality Control (QC)
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: 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
