Senior Specialist, Lead Investigator

The Senior Specialist, Lead Investigator plays a key role in ensuring investigations are completed with speed, rigor, and compliance to drive a culture of proactive issue resolution.

Responsibilities

• Conducts organized investigations with a well-defined scope, strategy, and timeline, documenting status and progress.
• Authors reports that document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent recurrence.
• Utilizes approved investigation tools to drive the team to root cause.
• Prioritizes work to aid in timely decisions and completion of investigations.
• Escalates issues as appropriate.
• Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
• Collaborates with a cross-functional team to determine:
  • Communication strategy for stakeholders.
  • Investigation strategy, including a clear and actionable problem statement.
  • Investigation tools and action plan with timing.
  • Root cause and solution selection.
  • CAPA action plan and effectiveness checks.
• Exercises independent judgment to advance investigations with minimal direction; coaches others and builds cross-functional alignment on root cause and corrective-action decisions.

Qualifications

• Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
• Familiarity with cGMP documentation practices and applicable regulatory requirements.
• Ability to quickly assess and assimilate technical data and conduct thorough investigations; ability to present findings, conclusions, and complex information clearly and concisely.
• Ability to manage multiple concurrent investigations, monitoring progress against objectives and timelines to drive timely closure.
• Excellent written, verbal, and presentation skills, including technical and investigation report writing.
• Ability to work in a fast-paced and rapidly changing environment.
• Ability to prioritize work activities to meet customer needs and deadlines.
• Ability to take accountability with excellent follow-up and follow-through; owns issues through the full investigation cycle.

Preferred Qualifications

• Bachelor’s degree, preferably in Science, Engineering, or other related technical discipline. Relevant work experience will be considered in lieu of a degree.
• 5+ years of experience in a pharmaceutical or other regulated manufacturing environment, including quality investigations and deviation management.
• Understanding of internal core business processes.
• Adept at identifying and understanding critical factors to generate appropriate solutions.
• Multiple site or function experience.
• Familiar with Lean problem-solving tools.

Physical & Work Environment

• Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.
• May require sitting, standing, walking, repetitive motion, and/or wearing personal protective equipment.

Schedule

8 hours per day, Monday through Friday. The Company reserves the right to modify work schedules based on business needs.

Pay

Target base pay hiring range for this position is $80,000.00 - $117,500.00 per year. Actual base pay is dependent upon geographical location, relevant experience, qualifications, skills, and knowledge.

Benefits

• Robust total rewards program, including an annual cash bonus program.
• 401(k) plan with a generous company match.
• Comprehensive healthcare benefits (medical, dental, and vision).
• Family-building benefits.
• Life and disability insurance.
• Paid vacation, holidays, and other leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.