BioPharma Consulting JAD Group

Technical Operations Investigator

Boston, Massachusetts, United StatesOn-siteContract

Salary not posted. The employer did not include pay in this listing. Ask for the range in your first conversation; it is a fair question.

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Should you apply?

Company website ↗

Open: 1 day; Fresh. First-week applicants get read first.
Open roles at this company: 3; A few open seats. Your application will get a real look.
Salary: Not posted; No range in the posting. Ask early. It is a fair question and it saves everyone time.

Days open comes from the posting date. Fill time and reposting rate come from this company's recent public postings.

The job, broken down

You'd investigate deviations and quality events at a pharma/biotech manufacturing site, finding root causes and building CAPA plans. This is a 12-month contract role, not full time employment.

What you'd actually do

Lead investigations into deviations, nonconformances, and quality events from start to finish
Gather data, interview staff, and review documentation to reconstruct what happened
Apply root cause tools like 5 Whys, Fishbone, Fault Tree, or Causal Factor analysis
Write clear, compliant investigation reports that meet GMP standards
Develop CAPA plans and work with process owners to implement and verify them
Run investigation meetings and cross functional problem solving sessions

Must-haves

BS in engineering, chemistry, biology, or related life science field
2+ years of relevant experience
Solid understanding of GMP and GDP regulatory expectations
Strong technical writing and documentation skills
Ability to interpret data and process performance indicators
Good communication and facilitation skills
Ability to manage several investigations at once

Nice to have

Hands-on experience with root cause analysis tools
CAPA development and effectiveness check experience
Background in pharma, biotech, medical device, or other regulated manufacturing
Experience with electronic quality systems like TrackWise or Veeva
Strong Excel, Word, and PowerPoint skills

Read before you apply

No pay rate listed anywhere in the posting
This is a contract position (12 months, possible extension), not permanent, despite job title sounding like a standard hire

Written from the posting text only. Check the full description below before you decide.

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Steps to get this job

1Rewrite your resume bullets to mirror their exact terms: 'root cause analysis,' 'CAPA plans,' '5 Whys,' 'Fishbone,' 'GMP,' 'deviations'
2Lead with any specific investigation you closed, including the root cause tool you used and the CAPA outcome
3If you've used TrackWise or Veeva, name them explicitly since they're called out as preferred systems
4Ask the recruiter directly about hourly/contract pay rate before investing more time, since it's not posted

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About the role

The Technical Operations Investigation Contractor is responsible for overseeing, conducting, and documenting investigations related to deviations, nonconformances, and quality events. This role ensures timely, thorough, and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). The role requires strong analytical skills, technical writing expertise, and the ability to collaborate across cross functional teams.

Key Responsibilities:

Lead end to end investigations for deviations and quality events.
Gather and analyze data, interview personnel, and review documentation to understand event details.
Apply structured root cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone, Fault Tree,).
Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
Identify true root causes supported by evidence.
Develop effective CAPA plans that address root causes and prevent recurrence.
Partner with process owners to ensure CAPA implementation, effectiveness checks, and closure.
Prepare clear, concise, and compliant investigation reports.
Ensure documentation meets GMP, and regulatory expectations.
Maintain high standards of accuracy, clarity, and traceability.
Work closely with Operations, Quality Assurance, Engineering, Maintenance, and other departments.
Facilitate investigation meetings and lead cross functional problem solving sessions.

Requirements

BS in engineering, chemistry, biology or life science related field
2+ years of experience

Required Knowledge & Skills

Strong understanding of GMP, GDP, and regulatory expectations.
Excellent technical writing and documentation skills.
Ability to interpret data, trends, and process performance indicators.
Strong communication, facilitation, and interpersonal skills.
Ability to manage multiple investigations simultaneously and prioritize effectively

Preferred Qualifications

Expertise in root cause analysis tools and structured problem solving.
Proficiency in CAPA development, implementation, and effectiveness evaluation.
Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
Familiarity with electronic quality systems (TrackWise, Veeva, etc.).
Background in engineering, life sciences, or a related technical field.
Strong technical writing, data analysis, problem-solving, and organizational skills.
Proficiency in Excel, Word, and PowerPoint.

Benefits

12-month contract with possible extension
Administrative shift

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