Senior Technical Writer
About The Position
The Technical Writer drives technical writing for GMP documents and investigations associated with New Jersey Stability Lab Operations in a fast-paced, multifaceted environment. Assignments vary in complexity and require sound judgment, initiative, and the ability to resolve problems and make recommendations or decisions. Technical writing and investigations must comply with applicable procedures, standards, GMP regulations, and local, state, federal, and international regulations and guidelines, including FDA, EPA, DEA, and OSHA requirements. The position develops and maintains laboratory documentation and investigation records, supports quality and compliance activities, advises on documentation gaps and process improvements, and provides technical-writing training and mentorship. The writer also supports escalations and Health Authority inspections and contributes to functional, continuous-improvement, and global project teams.
Requirements
- Detailed knowledge of analytical technologies used in QC laboratories, such as HPLC, Dissolution, IR, and Karl Fischer.
- Experience working as a bench analyst in a QC laboratory.
- Demonstrated use of root-cause analysis tools such as Kepner-Tregoe, Fishbone, and 5-Why.
- Strong written, verbal, and interpersonal communication skills, with attention to detail.
- Knowledge and understanding of current cGMP requirements related to the QC laboratory.
- Basic knowledge of compendial requirements (USP, EP, JP, etc.) relevant to the functional area of QC.
- Advanced technical-writing skills.
- Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Ability to complete investigations, including identifying root cause.
- Ability to collaborate and lead and influence investigation team members to coordinate work according to priorities.
- Experience with quality systems such as Trackwise, COMET, Docspace, TruVault, eLIMS, or equivalent.
- Ability to communicate clearly at all organizational levels.
- Ability to work independently on assignments with minimal oversight.
Nice To Haves
- Analytical reasoning
- Business behavior
- Compliance management
- Controls compliance
- Cross-functional collaboration
- Innovation
- ISO 9001
- Persistence and tenacity
- Problem solving
- Process oriented
- Quality auditing
- Quality Control (QC)
- Quality Control testing
- Quality standards
- Quality systems documentation
- Report writing
- Technologically savvy
Responsibilities
- Plan, execute, and write laboratory investigations in coordination with laboratory supervisors and QC Technical Leads, identifying immediate and root causes and determining effective corrective and preventive actions.
- Write and edit SOPs, validation protocols and reports, forms, analytical documents, and technical documents and reports from conception through utilization.
- Proofread documents for content, non-standard formatting or wording, and errors.
- Review relevant data pertaining to documents being drafted.
- Participate in technical-documentation gap assessments, confirm methods meet current standards and investigated processes are present and functioning optimally, and recommend solutions to address gaps.
- Present authorship strategies to management for pre-approval and endorsement.
- Build and maintain a progress-tracking matrix for document generation, qualification execution, document review, and approval; escalate issues or delays to management as appropriate.
- Collect and trend historical data.
- Prepare technical documentation for highly complex issues, including high-impact investigations.
- Contribute to improving laboratory investigation processes and templates.
- Train and mentor new investigation writers and laboratory analysts in technical writing.
- Maintain individual training completion in a compliant state.
- Complete investigation records and CAPAs in a timely and compliant manner.
- Provide information and support for escalations associated with laboratory investigations.
- Serve as a subject matter expert for Health Authority inspections.
- Provide input to functional laboratory meetings.
- Contribute to and occasionally lead continuous-improvement teams.
- Provide leadership and insight as a member of global project teams.
Benefits
- Company consolidated retirement plan (pension), subject to plan terms.
- Company savings plan (401(k)), subject to plan terms.
- Eligibility to participate in the long-term incentive program.
- Vacation: 120 hours per calendar year, subject to policy terms and date of hire.
- Sick time: 40 hours per calendar year, with different amounts for eligible Colorado and Washington residents.
- 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, or foster care of a child.
- Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver leave: 80 hours in a 52-week rolling period.
- 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
