QA Documentation Specialist (Pharma Experience Required)
Location: New Brunswick, NJ. This role is 100% Onsite
Duration: 5+ Months
Work Schedule: Mon - Fri, Business Hours
Job Description:
Principal Objective of the Position:
- Ensure compliance within the organization as it pertains to documentation and records management
- Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. DocMan) and Records Management Systems
- Generate metrics and support communication (i.e. upcoming periodic reviews, schedule for off-site storage and/or destruction)Key Responsibilities and Major Duties:
- Manages day-to-day operation and compliance of the New Brunswick Records Center, including issuance, archival, charge-outs, and reconciliation of GxP physical records including but not limited to equipment logbooks,laboratory notebooks, manufacturing batch records, and equipment qualification records. Coordinates offsiterecord storage and recall activities with Iron Mountain.
- Serves as Records Management System (RMS) Subject-Matter-Expert (SME) to enable successful execution of workflows within the system. Identifies opportunities for continuous improvement including need for systemenhancements through partnership with Global Quality Systems and Information Technology.
- Supports implementation of global quality system initiatives, including but not limited to electronic documentation systems and processes.
- Utilize the Records Management System to manage hardcopy GMP documents submitted for retention and archival.
- Provide support for procedural documentation requests, records management, issuance of logbooks/notebooks issuance, tracking and reconciliation for the NBR site.
- Completes routine tasks with little or no supervision.
- Requires moderate direction to complete more complex tasks
- Adherence to core behaviorsEducation and Experience:
- Minimum 4 years of quality experience in the pharmaceutical industry.
- Minimum 2 years of records mgmt. & document coordination experience using an electronic documentation system, preferably Veeva Quality Docs.
- Bachelor's degree preferred
- Minimum 4 years of quality experience in the pharmaceutical industry.
- Minimum 2 years of records mgmt. & document coordination experience using an electronic documentation system, preferably Veeva Quality Docs.
- Prior experience training end users on how to use quality systems and comply with procedures.
- Prior experience supporting closure of investigations and corrective actions.
- Ability to support day-to-day operation of NBR records center with limited supervision.
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Job Types: Contract, Temporary
Pay: Up to $30.00 per hour
Benefits:
- Dental insurance
- Health insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- What City/State are you currently located in?
- What hourly rate are you seeking on a W2?
Education:
Experience:
- Pharmaceutical Industry: 1 year (Required)
- training end users on how to use quality systems: 1 year (Preferred)
- supporting closure of investigations and corrective actions: 1 year (Preferred)
- quality experience in the pharmaceutical industry: 4 years (Preferred)
- records mgmt. & document coordination: 2 years (Preferred)
- electronic documentation system, Veeva Quality Docs: 2 years (Preferred)
Work Location: In person
