Technical Writer/Lead Investigator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Key Responsibilities:

• Conduct detailed and structured investigations through data collection, collaboration, and analysis to determine root causes.
• Act as a method SME for root cause analysis tools (e.g., 6M, Fishbone, TapRooT) and general problem-solving techniques.
• Lead, initiate, and assist with the completion of immediate corrections and CAPA items, ensuring they are robust and pertain to the assignable root causes.
• Ensure the quality impact on both the patient and the product is assessed against applicable regulatory guidelines.
• Identify and address activities and barriers associated with investigation planning and completion.
• Write reports and summaries clearly and promptly to ensure timelines are met and information is accurately conveyed.
• Compile Key Process Indicators (critical metrics) for investigations.
• Champion projects associated with improvements to investigations and be a site champion.
• Engage in and adhere to departmental systems to maintain a smooth and efficient workflow, including visual management and scheduling systems.
• Foster a culture of collaboration, flexibility, and continuous improvement by growing business and industry knowledge, and improving executional skills.
• Mentor and train junior investigation team members, providing oversight and mentorship.
• Offer investigation expertise for complex deviations to the site.

Educational and Experience Requirements:

• Bachelor's Degree in Science and/or Engineering, or equivalent experience.
• Minimum of 5 years in a cGMP environment within the pharmaceutical, food, or cosmetic industry.
• Minimum of 3 years of experience in technical or scientific writing principles.
• Demonstrable knowledge of cGMP principles pertaining to investigations and CAPA actions.
• Experience in practical problem-solving and continuous improvement projects.
• Proficiency with TrackWise and TapRooT or other Root Cause Tools.
• Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint).
• Understanding of learning methodologies and ability to mentor and train others.
• Experience with training technical writing skills and Root Cause Analysis Tools preferred.

Physical Demands:

The employee will need to walk, sit, use hands, reach, balance, stoop, crouch, bend, talk, and hear. They will usually work indoors but may experience mild physical discomfort like dust, fumes, temperature extremes, loud noise, drafts, or bright lights.

Work Environment:

This job operates in a professional office environment as well as the Production and Warehouse environments in a pharmaceutical facility. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of work, responsibilities, or requirements. Other duties may be assigned as needed.

Compensation and Benefits

The salary range estimated for this position based in Illinois is $75,800.00-$113,675.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit:

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