USA-Documentation Specialist II (Manufacturing/Quality)- First Shift - Randstad USA

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. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Waltham, Massachusetts
job type: Contract
salary: $43.00 - 45.81 per hour
work hours: 8 to 4
education: High School
 
responsibilities:

Document Control:

- Run Daily Report - QualiPSO Veeva Documents

- Accept/Closed DCR's

- Assist with procedure assignment in curriculums (assist training coordinator)

- Assist with paper document archiving and indexing

- Assist with logbook/MMRs/BMRs management where needed - scanning, archiving, closing out request forms

- Attend meetings as needed.

- Assist with Document Vault

- Assist with general DC support

Quality Systems:

- Support and manage TPCN Change Controls (CC)

- This role will require ensuring all CC details are populated accurately, launching/starting the CC, assigning a change plan owner and working with change plan owner with SME Impact assessments and more.

- Support and manage Third Party (TP) Quality Events

- Track all significant TP events, manage reoccurring meetings, work with owners and quality reps

- Third Party (TP) Management

- Conduct TP Initial Risk Assessments and ensure SMEs perform annual performance - Veeva QTP Support

- Ensure all associated TP Entities are active in the database and all materials/services/agreements are in place and accurate

- General QS support

 
qualifications:

- Min HS diploma but 5-7 years experience.

- Must have experience with Veeva and experience supporting and managing TPCN Change Controls (CC), Experience tracking all significant TP events, manage reoccurring meetings, work with owners and quality reps.

- Conduct TP Initial Risk Assessments and ensure SMEs perform annual performance assessments.

 
skills: Quality control

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.