compliance specialist - level 2 us- first shift.
cambridge , massachusetts
posted today
job detailssummary
$50 - $53.19 per hour
contract
bachelor degree
category life, physical, and social science occupations
reference48172
job detailsjob summary:As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report to the QMS Manager.This position provides the opportunity to work directly with Manufacturing, Facilities, QA, and QC staff to manage QA Compliance activities for the Binney St. site in Cambridge, MA. The primary focus of this role will be to support management of Quality Systems (deviation, CAPA, and change control). Other activities may arise.location: Cambridge, Massachusettsjob type: Contractsalary: $50.00 - 53.19 per hourwork hours: 9 to 5education: Bachelorsresponsibilities:
Manage overall health of Quality Systems by trending Key Performance Indicators (KPIs) to support continuous improvement and to identify, escalate, and resolve abnormalities or concerns.
Ensure quality operations and processes are in full compliance with company standards and policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and local regulatory requirements.
Compile and analyze metrics for documentation, deviation, CAPA, and change control. Develop and maintain dashboards and presentation graphics on a regular basis.
Coordinate and facilitate recurring governance meetings with task owners across departments to manage timelines.
Lead improvement projects to streamline and simplify processes in alignment with company standards and regulations.
Perform Quality System process confirmations to ensure processes and systems are appropriately managed. Ensure audit readiness for Quality Systems at the site.
Support Quality Systems risk identification and timely mitigation activities.
qualifications:
Bachelor's degree or equivalent experience.
3+ years of related experience.
High attention to detail
Strong analytical and organizational skills
Familiarity with Quality Systems (deviations, CAPAs, and change controls)
Proficiency in: Excel and Smartsheet data analysis
Making clear, concise, and consistent Powerpoint presentations
Confident facilitation skills to lead governance meetings and work with task owners to monitor timelines
Professional demeanor when presenting to senior leadership
skills: MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)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).Applications accepted on ongoing basis until filled.