- The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the Company network.
location: Telecommute
job type: Contract
salary: $35.00 - 47.11 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.
- Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process
- Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management
qualifications:
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience.
- Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
- Basic knowledge of Veeva or Trackwise
- Biotech industry experience
skills: GMP (Good Manufacturing Practice), Veeva Vault Safety, PV CAPA Management, Veeva Vault, Corrective and Preventive Actions (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: 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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
