Title: Technical Writer
Duration: 12 months
Location: Bothell, WA
Pay: $62.69/hr
Schedule: 1st Shift
TOP SKILLS:
- Minimum of 5-8 years’ experience in a GMP laboratory environment. At least 5 years’ experience in writing and reviewing standard operating procedures.
- Experience with Veeva EDMS preferred, or similar
- Experience with ERP, SAP Preferred, revising or creating new documents
- Experience working cross functionally, communication and customer service skills.
Key Responsibilities and Major Duties
- Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.
- Ability to interview cross functional subject matter experts and translate their description into actionable instructions- Work Instructions, Job Aids using the templates prescribed by corporate policy.
- Schedule cross functional team meetings, collect feedback, create draft documents, post on sharepoint, schedule reviews, collect and resolve feedback.
- Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
- Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
- Work independently but recognize need to consult stake holders and keep them informed of progress.
- Identify and lead improvement efforts within current procedures.
- Maintain a good understanding of ICH Guidelines, regulations and other guidelines applicable to GMPs.
- Ability to negotiate and influence solutions without direct authority.
- A self-starter with an ability to manage electronic systems with minimal training and supervision.
Requirements
- - Minimum of 5-8 years’ experience in a GMP laboratory environment. At least 5 years’ experience in writing and reviewing standard operating procedures.
- - Experience with Veeva EDMS preferred, or similar
- - Experience with ERP, SAP Preferred, revising or creating new documents
- Experience with microbiology testing is a plus.
- Demonstrated ability to successfully manage competing deadlines and balance priorities.
- Excellent technical writing skills, close attention to detail and excellent follow up.
- Expertise in Microsoft Word and Share Point.
- Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
Thanks
Sajid Sarkar
Pharma Recruiter
Sarkar.Sajid@net2source.com
(201) 266-0245 Ext.329
270 Davidson Ave Suite 704
