Senior Technical Writer
About The Position
The Technical Writer is responsible for driving results in a fast-paced multi-faceted environment by leading the technical writing of GMP documents and investigations associated within the NJ Stability Lab Operations. Assignments are of varying complexity, where sound judgement and self-drive/initiative are required to resolve problems and make recommendations/decisions. This position requires technical writing and investigations to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.).
Responsibilities
- Provide project/study and investigation support through review and technical writing of GMP documents (e.g. study specific protocols or validation reports), SOPs and other documents associated within QC area of responsibility.
- Uphold our Credo values including creating a positive work environment.
- Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
- Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying assignable/root causes and determining effective corrective and preventative actions.
- Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization.
- Proofread documents for content and identify non-standard format or wording, and errors within documents.
- Review data where required pertaining to documents being drafted
- Participate in gap assessments of technical documentation to ensure methods are up to current standards, and that processes investigated are present and functioning optimally.
- Provide recommendations/solutions to remediate any recognized gaps.
- Present authorship strategy to management to get pre-approval and Endorsement.
- Build and maintain a progress-tracking matrix on document generation, qualification execution, document review and approval (Escalate any issue/delay to management as applicable).
- Collect and trend historical data.
- Responsible for preparing technical documentation for highly complex issues (i.e. high impact investigations).
- Make contributions to improved processes and templates as it relates to laboratory investigations.
- Provide training and mentorship for new investigation writers and lab analysts as it pertains to technical writing
Benefits
- employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
