Medical Documentalist Pharmaceutical Company

5 days ago


New Brunswick, New Jersey, United States ProStaff Solutions Inc Full time
About ProStaff Solutions Inc:
We are a fast-growing and successful agency that treats all its clients and candidates with a personal touch. Our mission is to bring the right people to the right job every time, bettering people's lives and increasing our customers and employees' success.

Job Overview:
As a skilled Pharmaceutical Technical Writer, you will play a key role in our team's success. You will be responsible for performing investigations and assisting manufacturing and packaging operations on investigations, Product quality complaints. You will also assist in cross-functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls.

Responsibilities:
  • Ensure timely closure of all manufacturing/packaging and Quality Management System records.
  • Organize and participate in reviews of cross-functional investigation's
  • Represent Operations at cross-functional meetings.
  • Work with process owners and SMEs to implement agreed-upon procedural documentation and to develop cross-functional process models
  • Collect input from stakeholders and consolidate comments for conflict resolution
  • Drive the improvement in established KPI's / metrics for manufacturing and packaging departments
  • Assist operations in responses to any internal audit, corporate audit, or regulatory audit observations involving manufacturing or packaging Control.
Estimated Salary: $55,000 - $75,000 per year.

Required Qualifications:
  • Associate degree in Life Sciences, Pharmacy, or equivalent required.
  • Minimum of three years working in a pharmaceutical environment with at least two years of experience within manufacturing area.
  • Demonstrated excellent communication: verbal, written, and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • A team-building champion driving innovative cross-functional synergies.
  • Excellent project management and problem-solving skills.
  • Excellent computer skills; MS Office (Word, Excel, PowerPoint), Trackwise, EDMS, Outlook.
  • Knowledge of GDP, GMP, QA Documentation, QA Batch records, Quality Systems, Archiving, Retrieval, EDMS workflow, Document Life Cycle, and Audit Compliance.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).


Why Choose Us:
We offer a competitive compensation package as well as an excellent benefits package for eligible candidates, including health insurance, 401(k) matching, and paid time off.

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