Pharmaceutical Technical Writer - 14020489

Job Description
Are you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a Pharmaceutical Technical Writer to join their New Brunswick, New Jersey team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.

Full-time Onsite
Direct Hire
Pay Rate: DoE

Job summary:
Perform investigations and assist manufacturing and packaging operations on investigations and product quality complaints. Assist in cross-functional investigations for out of specification (OOS), out of trend (OOT), laboratory events, CAPAs, and change controls.

Areas of responsibility:

• Ensure timely closure of all manufacturing/packaging and Quality Management System records.
• Organize and participate in reviews of cross-functional investigations.
• 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.

Travel Estimate: Up to 5%

Required Qualifications:

• Associate degree in Life Sciences, Pharmacy, or equivalent required.
• Minimum of three (3) years working in a pharmaceutical environment with at least two (2) years of experience within the 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), Track wise, 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 proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for (CEFR).

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.

About ProStaff Workforce Solutions
We are a fast-growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instills confidence and trust in our client companies and candidates.

Our Values
• Integrity
• Commitment
• Quality

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

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