Quality - Technical writer
Apply NowCompany: Futran Tech Solutions Pvt. Ltd.
Location: Seattle, WA 98115
Description:
Job Description: Job Title: Technical Writer
Location: Seattle-Dexter
Hybrid - (Flexible days - 50% + onsite)
Top Skills:
- Bachelor's degree required - Life Sciences degree preferred
- Minimum of 1-3 years' experience in a GMP environment.
- 1-3 years' experience with GMP labelling is preferred.
- Experience with Oracle and/or SAP preferred.
POSITION SUMMARY
The Technical Writer will manage and oversee data input and documentation management and functions as detailed below to ensure delivery of Cell Therapy labelling projects.
Key Responsibilities and Major Duties
Write and revise standard operating procedures (SOPs) and specifications for GMP Labelling operations
Complete intake forms and follow up on item creation process with cross functional stakeholders.
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, 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 document periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
Maintain a good understanding of regulations and other guidelines applicable to GMPs.
Requirements
Minimum of 1-3 years' experience in a GMP environment.
1-3 years' experience with GMP labelling is a plus.
Experience with Oracle and/or SAP a plus.
Demonstrated ability to successfully manage competing deadlines and balance priorities.
Ability to track and follow up on multiple workstreams and escalate when appropriate.
Expertise in Microsoft Word.
Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
Bachelor's degree required - Life Sciences degree preferred
The starting hourly compensation for this assignment is a range from $42.64 - $54.16. While the final, individual compensation will be determined by your employer of record (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
Additional Sills:
Location: Seattle-Dexter
Hybrid - (Flexible days - 50% + onsite)
Top Skills:
- Bachelor's degree required - Life Sciences degree preferred
- Minimum of 1-3 years' experience in a GMP environment.
- 1-3 years' experience with GMP labelling is preferred.
- Experience with Oracle and/or SAP preferred.
POSITION SUMMARY
The Technical Writer will manage and oversee data input and documentation management and functions as detailed below to ensure delivery of Cell Therapy labelling projects.
Key Responsibilities and Major Duties
Write and revise standard operating procedures (SOPs) and specifications for GMP Labelling operations
Complete intake forms and follow up on item creation process with cross functional stakeholders.
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, 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 document periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
Maintain a good understanding of regulations and other guidelines applicable to GMPs.
Requirements
Minimum of 1-3 years' experience in a GMP environment.
1-3 years' experience with GMP labelling is a plus.
Experience with Oracle and/or SAP a plus.
Demonstrated ability to successfully manage competing deadlines and balance priorities.
Ability to track and follow up on multiple workstreams and escalate when appropriate.
Expertise in Microsoft Word.
Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
Bachelor's degree required - Life Sciences degree preferred
The starting hourly compensation for this assignment is a range from $42.64 - $54.16. While the final, individual compensation will be determined by your employer of record (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
Additional Sills: