DUTIES: Technical writing support for deviation and investigation report writing, as well as Corrective and Preventative Action plans (CAPAs) in accordance with GMPs.
Facilitate the development and standardization of quality products through participation and representation on group and department level project teams.
Draft and revise Analytical Development (AD) protocol, method, and report templates along with other documentation necessary to ensure the qualification of methods.
Prepare documents and facilitate circulation for review and approval to meet project timelines.
Edit documents for grammar, spelling, format, and style according to established guidelines.
Create necessary guidelines to standardize document content.
Consult with technical personnel on process requirements and specifications as well as consult relevant SOPs to assure compliance.
Complete necessary support tasks for document issuance.
Obtain information in a timely manner, manage document changes from many sources, prioritize work to meet tight timeframes, build consensus with multiple reviewers and work to meet the department Right First Time and On Time Delivery metrics.
Participate in continuous improvement projects.
Develop documentation processes.
Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results.
Record and report results of analysis in accordance with prescribed lab procedures and systems.
Coordinate and lead writing of SOPs, policy manuals, and other instructional documents.
Conduct training of AD staff on new or revised processes associated with document management systems.
Coordinate the development of training curricula.
Assist with training and guidance of Analytical Development personnel as appropriate.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
Maintain the necessary compliance status required by company and facility standards.

REQUIREMENTS: PhD in Chemistry, Biological Sciences, or related field of study plus 1 year of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience. Employer will also accept a Bachelor’s degree in Chemistry, Biological Sciences, or related field of study plus 5 years of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience. Employer will also accept a Master’s degree in Chemistry, Biological Sciences, or related field of study plus 3 years of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience.

Must have experience or knowledge of:

Manufacturing practices;
Quality and laboratory systems;
Microsoft Office, including MSWord and MSExcel;
Presenting information to customers, clients and other employees;
Reading, analyzing, and interpreting technical procedures and governmental regulations;
Writing standard operating procedures and policy manuals; and
Responding to complex inquires or complaints from customers or regulatory agencies.

Travel: Up to 25% domestic and international travel required. Telecommuting Employee: Reports to company headquarters in Waltham, MA. Cam work remotely or telecommute.

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