Technical Writer

ProStaff Workforce Solutions is seeking Technical Writer for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.

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Full Time Onsite
Contract

Job Description:
The Technical Writer provides support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards.

Area of Responsibility: 

• Collaborate with manufacturing, plant services, engineering to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
• Work directly on technical investigations relating to product quality complaints
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Author/revise standard operating procedures (SOPs) and batch records, as required
• Other duties as assigned

Qualifications:

• BS in chemistry or related scientific field, or equivalent education and experience
• Minimum 2-4 years related experience in a pharmaceutical manufacturing environment
• Working knowledge of cGMPs
• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
• Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
• Strong working knowledge of MS Office software
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and projects in a fast-paced environment, while performing in an efficient manner

About ProStaffworkforce Solutions
We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaffworkforce 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 instill confidence and trust in our client companies and candidates.

Our Values
• Integrity
• Commitment
• Quality
• Diversity

Benefits for eligible employees
• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan

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