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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

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 judgment 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.)

• Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying immediate/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

• Maintain individual training completion in a compliant state

• Complete investigation records and CAPAs in a timely and compliant fashion

• Provides information and support to escalations associated with laboratory investigations

• Support as SME for Health Authority Inspections

• Provide input to functional laboratory meetings

• Make contributions to, and occasionally lead, continuous improvement teams

• Provide leadership and insight as a member of global project teams

Required Knowledge, Skills and Abilities:

• Detailed knowledge of analytical technologies used in the QC laboratory (HPLC, Dissolution, IR, Karl Fischer, etc.)
• Experience working in a QC laboratory as a bench analyst
• Demonstrated use of root cause analysis tools such as Kepner-Tregoe, Fishbone, 5-Why, etc.
• Demonstrated written, verbal, and interpersonal communication skills with strong attention to detail
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Advanced technical writing skills
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
• Ability to complete investigations including identification of root cause
• Ability to work collaboratively and to lead and influence investigation team members to coordinate work based on priorities.
• Experience with Quality Systems such as Trackwise, COMET, Docspace, TruVault, eLIMS or equivalent required
• Able to communicate clearly at all levels of the organization required
• Ability to work independently on assignments with minimal oversight required
  
  

Required Skills:

 

 

Preferred Skills:

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

 

 

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, 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.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits