You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Our client is seeking an Investigator to lead and author high-quality GMP investigations for incidents, deviations, and EM/aseptic or utility excursions in a 503B sterile operation. The role involves driving true root cause, scope/lot impact, risk assessment, and effective CAPA/Change Control so batches can be confidently dispositioned by QCU. The Investigator will be the site’s investigation writing expert and coach for cross-functional SMEs.
Key Responsibilities
- Intake & triage: confirm immediate containment, open investigation in eQMS, define a clear problem statement, build a factual event timeline and Gemba notes.
- Evidence management: gather batch records, EM maps/plates, lab data, maintenance/alarms, training, and change history; ensure traceability of raw data and audit trails.
- Root-cause analysis: lead/coach 5-Whys, fishbone, barrier/Kepner-Tregoe; separate human-error types (skill, rule, knowledge), test hypotheses, and confirm true cause with data.
- Risk & scope: perform ICH Q9 risk assessments; determine potentially affected lots, processes, or customers; recommend holds and testing as needed.
- Write the investigation: produce a tight narrative covering problem, containment, cause, risk/impact, corrective & preventive actions, and effectiveness checks; cite evidence and attachments.
- CAPA planning & effectiveness: define measurable actions, owners, and due dates; verify completion and effectiveness criteria; link to Change Control as required.
- On-site role with frequent Gemba in ISO 7/8 areas (observe ISO 5); ability to be gown qualified.
- Special cases: handle specific instances like OOS/OOT, EM/aseptic events, and utilities excursions in coordination with relevant teams and guidelines.
- Metrics & trends: maintain dashboards for cycle time, quality score, repeat issues; present weekly burn-down and monthly Management Review inputs.
- Coaching & standard work: maintain investigation templates, checklists, and RCA toolkit; train SMEs and reviewers.
- Inspection readiness: prepare investigation binders, manage records during audits, and support responses to 483/observations.
Qualifications
- BS/BA in Microbiology, Chemistry, Pharmacy, Engineering, or related field.
- 5+ years in GMP pharma/biotech with 2+ years leading investigations; sterile/503B experience strongly preferred.
- Deep knowledge of 21 CFR 210/211 (esp. 211.192 investigations), FDA Aseptic Processing Guidance, 503B guidance, Part 11/Data Integrity (ALCOA+), and basics of ISO 14644 and USP 71/85/788.
- Proficient with RCA methods and statistics for trending (control charts, Pareto, run charts).
- Exceptional technical writing and facilitation; calm and credible during audits.
Benefits
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
- 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
Required Employment / Compliance Language
Our client complies with all applicable laws concerning hiring and employment practices, and makes reasonable accommodations to qualified applicants with disabilities.
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
