Qc Sr Technical Writer - 16179465

Are you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a QC Senior 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.
Direct Hire
Job Summary
To author technical documents such as analytical methods, specifications, validation protocols validation reports, transfer protocols, SOPs accordingly to the company’s standards and FDA /ICH guidelines. To review USP changes in a timely manner and update the related documents to implement the changes.
Responsibilities

• Oversees method/specification and Laboratory SOP creation process.
• Writes/review/approve technical documents such as method, specifications, validation protocols, validation reports, transfer protocols and reports, SOP’s based on corporate policies, compendia requirements, ICH and FDA guidelines.
• Initiate and review the change controls for method/specification and SOP revisions and ensure they are closed on time.
• Communicate the cross function team about changes in specification and method.
• Evaluate the specification and method changes performed by vendor and ensure their appropriate implementation.
• Shared the specification and methods will cross function team for review and approval.
• Perform the actions assigned as part of CAPA.
• Control the Mater copies of method and specification.
• Issue the control copies to QC for use, maintain appropriate documentation and ensure retired copies are archived.
• Evaluates compendia documents, and reviews procedures for analytical development and validation.
• Must have an appropriate understanding of ICH and FDA regulatory guidance’s needed to prepare documents properly.
• Assigns document numbers. Maintains hard copies and electronic files of technical documents.
• Communicates with raw material manufacturer for any technical information.
• Provide the documents required for CBE, PAS and ANDA submission to RA in a timely manner.         

Job Qualifications

• Minimum of a B.S. in a scientific field
• Minimum eight (8) years of experience in pharmaceutical analytical laboratory along with technical writing.
• Excellent computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
• Hands on experience with TrackWise, LIMS and Document Management System.
• A self-starter with a hands-on approach and a can-do attitude.
• Excellent project management and problem solving skills.
• Strong written and oral communication skills.
• Must be able to work independently.
• Must have an understanding of FDA and DEA regulations.
• Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
• Collaborates with colleagues and external partners to achieve primary Department goals.
• Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management.
• Works in coordination with project plans and goals as assigned by Management.
• 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).

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
#ps

Prostaff Solutions is committed to all aspects of staffing services
We offer comprehensive best-practices for our clients and employees.
Our Vision:
ProStaff Solutions strives to be the premier employment solutions provider to every community we serve.
Our Mission:
Our mission is to bring the right people to the right job every time. Accomplishing this, we better people's lives and increase our customers and employees success.
Our Values :
Our Pledge of Integrity
Our name is the most important thing we own. To us, it is more than an identity. It is also how we act. It is both the foundation and the heart of our business.
Because our success depends on our personal integrity and honesty, we work hard. We also reward hard work. We believe great things happen when we listen to each other, and that is why our doors are always open. We also strive to strengthen our communities by example in leadership, and by donations of time and resources.