QC Microbiology Data Reviewer and Writer

Indianapolis, IN

Apply Apply with LinkedIn
Save

Type: Contract

Experience: 0

Category: Scientific & Clinical

Contractor Work Model: Onsite

Brand: Joulé

Job ID: 344196

Date Posted: 12/15/2025

Shortcut: http://jobs.systemone.com/xrEgTS


Job Title: QC Microbiology Data Reviewer and Writer
Location: Indianapolis, IN
Hours/Schedule: Monday - Friday, Business Hours
Type: Contract
 
Overview
Leading pharmaceutical company looking for an experienced QC Microbiology Data Reviewer. Ideal candidates should have 4 years of experience in GMP Microbiology laboratory data Review. As well as experience writing and supporting investigations, deviations, or CAPA processes. 
 
Responsibilities
• Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance
• Verify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring
• Confirm adherence to SOP’s, test methods, and approved protocols
• Ensure documentation meets ALCOA+ data integrity principles
• Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation
• Review EM results and ensure proper escalation of out of trend or excursions findings
• Write deviations, CAPAs and revise SOP’s
• Write monthly / quarterly reports for environmental monitoring
• Support internal and external audits by providing clear, complaint documentation
 
Requirements
Qualifications
• Minimum 4 years’ experience in GMP microbiology laboratory data review
• Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring
• Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
• Experience with Sherpa or other LIMS
• Intermediate level MS SharePoint experience
• SAP experience preferred

Education:
• Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent
• Preferred training in Quality systems, cGMP, and Data Integrity


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 


 

Ref: #558-Scientific

  • Quality Control Inspector

    Exton, PA

    Job Title: Quality Control Inspector Location: Exton, PA Type: Contract to hire Schedule: Monday-Friday 8am-5pm Pay Rate: $30/hour Overview: Growing Pharmaceutical Company is seeking an experience Quality Control Inspector to join their team on a contr...

    Date Posted: 11/26/2025 Recommended

  • System Support Analyst

    Indianapolis, IN

    Job Title: CAPA System Support Analyst Location: Indianapolis, IN Hours/Schedule: Monday–Friday, 8 am to 5 pm (Hybrid) Type: Contract Overview The CAPA System Support Analyst manages service operations supporting digital health software and data system...

    Date Posted: 12/12/2025 Recommended

  • Global Supplier Quality Management Representative

    Indianapolis, IN

    Job Name: Global Supplier Quality Management Representative Location: Indianapolis, IN Work Schedule: Mon - Fri 8am - 5pm Pay Range: $32.60 - $38.35 Type: Contract, Potential for extension or conversion to permanent Overview: The Global Supplier Qualit...

    Date Posted: 12/08/2025 Recommended

  • Global Supplier Quality Management Representative

    Indianapolis, IN

    Job Name: Global Supplier Quality Management Representative Location: Indianapolis, IN Work Schedule: Mon - Fri 8am - 5pm Pay Range: $32.60 - $38.35 Type: Contract, Potential for extension or conversion to permanent Overview: The Global Supplier Qualit...

    Date Posted: 12/08/2025 Recommended

  • Manager - QA Microbiology

    Fairfield, New Jersey

    Job Title: Manager - QA Microbiology Location: Fairfield, New Jersey Hours / Schedule: Monday–Friday, 7:00 AM–3:00 PM (40 hours/week) Type: Contract Compensation: $32 per hour Position Overview We are seeking an experienced 1st shift QA Microbiology Ma...

    Date Posted: 12/05/2025 Recommended

  • QC Compliance Manager

    Pennington, NJ

    Job Title: QC Compliance Manager – Biologics / Biosimilars Location: Greater Princeton, NJ area Employment Type: Direct Hire (Onsite) Schedule: Full-Time, Day Shift (M–F, 8–5 with flexibility) Compensation: $94,000–$124,000 (depending upon experience) ...

    Date Posted: 12/16/2025 Recommended

  • Manufacturing Operator

    Indianapolis, IN

    Job Title: Manufacturing Operator Location: Indianapolis, IN Work schedule: 5:45pm- 6am, 3 work shifts, 2 off shifts, 2 work shifts, 3 off shifts Type: Contract Overview Global pharma company looking for experienced manufacturing operators to join thei...

    Date Posted: 10/31/2025 Recommended

  • Technical Writer

    Melbourne, FL

    Job Title: Technical Writer Location: Melbourne, FL Type: Contract To Hire Compensation: $40-45/hr Contractor Work Model: Hybrid As a IT Technical Writer you will be responsible for creating and maintaining technical documentation, manuals, user guides...

    Date Posted: 12/16/2025 Recommended

  • GMP Laboratory Technician

    Pittsburgh, PA

    Title: GMP Laboratory Technician Location: Onsite, Pittsburgh, PA 15219 Type: 6-month contract to hire Hours:Monday to Friday, 8AM-5PM Start: January Overview: Join a Cell Therapy manufacturing department in which you will play a critical role in produ...

    Date Posted: 12/16/2025 Recommended

  • CMC Data Integration Specialist

    Indianapolis, IN

    Job Title: CMC Data Integration Specialist Location: Indianapolis, IN (Hybrid) Hours/Schedule: Monday–Friday, 8 am to 5 pm Type: Contract Overview The CMC Data Integration Specialist will support data migration and process improvement initiatives withi...

    Date Posted: 10/22/2025 Recommended

  • Recruiting Associate

    Indianapolis, IN

    Job Title: Recruiting Associate Location: Indianapolis, IN Work Schedule: Mon - Fri 8am - 5pm Pay Range: $30.00 - $38.95/hr Type: Contract, Potential for extension or conversion to permanent Requirements Basic Requirements: • Bachelor’s Degree OR High ...

    Date Posted: 12/10/2025 Recommended

  • Quality Control Analyst II / III - Biologics

    Piscataway, NJ

    Job Title: Quality Control Analyst II/III Location: Piscataway, NJ (Onsite: some travel to South Plainfield) Hours / Schedule: Monday-Friday, 8:30AM-5:00PM (with occasional early / late hours once per month during production runs) Type: Direct Hire Com...

    Date Posted: 12/16/2025 Recommended

  • Niche - Content Designer/UX Writer

    Strongsville, OH

    Title: Content Designer Location: Pittsburgh, PA/Strongsville, OH/Dallas, TX/Phoenix, AZ or Remote Function of the Group: Combo of Mitigating Risk and Generating Revenue Initiatives/Projects: Personalization, additional content design support across mo...

    Date Posted: 11/19/2025 Recommended

  • Quality Compliance Associate

    East Windsor, NJ

    Job Title: Quality Compliance Associate Location: East Windsor, New Jersey Type: Contract Compensation: $26 - $36 per hour Contractor Work Model: Onsite Hours: 8/9 AM – 5/6 PM, Monday to Friday Industry: Pharmaceuticals, Sterile Injectable Products Res...

    Date Posted: 12/04/2025 Recommended

  • Nuclear Plant Program Specialist and Procedure Writer 

    Bellevue, WA

    Job Title: Nuclear Plant Program Specialist and Procedure Writer Location: Bellevue, WA Type: Contract Contractor Work Model: Remote Position Overview: As a Nuclear Plant Program Specialist and Procedure Writer, you will play a pivotal role in the proc...

    Date Posted: 11/17/2025 Recommended

  • Manufacturing Associate (Upstream & Downstream)

    Pennington, NJ

    Job Title: Manufacturing Associate (Upstream & Downstream) Location: Princeton Area, New Jersey Hours / Schedule: Full-time, shift flexibility required (day, evening, overnight rotation possible, overtime available based on production needs) Type: Temp...

    Date Posted: 11/25/2025 Recommended

  • Chemistry Specialist and Procedure Writer 

    Bellevue, WA

    Job Title: Chemistry Specialist and Procedure Writer Location: Bellevue, WA Type: Contract Compensation: $84 - $135 hourly Contractor Work Model: Remote Key Responsibilities: Procedure Development: Create, organize, and track Chemistry procedures tailo...

    Date Posted: 12/01/2025 Recommended

  • Quality Control Associate I

    South San Francisco, CA

    Job Title: Quality Control Associate I Location: South San Francisco, CA Type: Contract Compensation: $25 - $29.26/hr Job Description: The job responsibility within the PTDA Bioassay US Testing Group is to perform biochemical/immunological and cell-bas...

    Date Posted: 12/16/2025 Recommended

  • Chemist I

    Wilson, NC

    Job Title: Chemist I Location: Wilson, NC Type: Contract Compensation: $25/hour Contractor Work Model: Onsite Hours: Monday-Thursday 10hr shifts - 7AM – 5:30 PM with some flexibility in start time Responsibilities: Performs a variety of chemical analys...

    Date Posted: 12/12/2025 Recommended

  • Clinical Research Coordinator

    Plano, Texas

    Job Title: Clinical Research Coordinator Location: Plano, TX, 75230 - 100% onsite (must currently reside in TX) Schedule: Monday–Friday Type: Contract Joule is seeking a Clinical Research Coordinator to support a Clinical Research Trial at a Plano TX h...

    Date Posted: 12/16/2025 Recommended

  • GMP Manufacturing Equipment Supervisor

    Cranbury, NJ

    Job Title: GMP Manufacturing Equipment Supervisor Location: Cranbury, NJ Hours / Schedule: M-F; some flexibility with start time; 8am - 5pm Type: Contract to Hire Compensation: Approximately $38 - $40 per hour pending overall experience Summary The Mai...

    Date Posted: 12/03/2025 Recommended

  • Quality Laboratory Manager

    Freehold, New Jersey

    Job Title: Quality Laboratory Manager Location: Freehold, NJ Type: Direct Hire Compensation: $80000 - $90000 annually Contractor Work Model: Onsite Hours: Monday-Thursday 8 am till 5 pm & Fridays 8 am till 2 pm Quality Laboratory Manager Key Responsibi...

    Date Posted: 11/17/2025 Recommended

  • Document Control Specialist

    Round Lake, IL

    Job Title: Manufacturing Document Technician I Location: Round Lake, IL Hours/Schedule: Monday–Friday, 8 am to 5 pm (Some weekend work required) Type: Contract Overview The Manufacturing Document Technician supports quality systems by creating, verifyi...

    Date Posted: 12/11/2025 Recommended

  • Clinical Supplies Associate

    Basking Ridge, NJ

    Title: Clinical Supplies Associate Location: Basking Ridge, NJ (Hybrid; onsite 2 days per week) Type: 12 Month Contract Schedule: M-F Day Pay: $30-34/hour Responsibilities: Monitor and assess temperature data for clinical trial shipments and on-site st...

    Date Posted: 10/17/2025 Recommended

  • Analytical Chemist II

    Richmond, VA

    Job Title: Analytical Chemist II Location: Richmond, VA Type: Contract Job Description: The Senior Scientist role will be responsible for assessing, developing, and validating analytical methods for Dietary Supplements and Over the Counter Products to ...

    Date Posted: 11/20/2025 Recommended

  • Project / Mechanical Engineer

    Sapulpa, OK

    Job Title: Project/Mechanical Engineer Location: Sapulpa, OK Compensation: $80000 - $90000 annually Contractor Work Model: Onsite Job Summary: The Project Engineer works to plan projects, establish project criteria, coordinate project reviews and ensur...

    Date Posted: 12/02/2025 Recommended

  • Production Operator

    Orangeburg, NY

    Title: Production Operator Location: Orangeburg, NY area Start Date: ASAP!! Duration: 6+ Month Contract (possible Contract-to-Hire) Hours: Monday-Friday; 2nd Shift: 12pm-8:30pm Duties/Responsibilities: Maintains all production areas in a clean and orde...

    Date Posted: 12/13/2025 Recommended

  • Filling Operator

    Orangeburg, NY

    Title: Filling Operator Location: Orangeburg, NY area Start Date: ASAP!! Duration: 6+ Month Contract (possible Contract-to-Hire) Hours: Monday-Friday; 2nd Shift: 12pm-8:30pm Duties/Responsibilities: Maintains all production areas in a clean and orderly...

    Date Posted: 11/20/2025 Recommended

  • Production Operator

    Orangeburg, New York

    Title: Production Operator Location: Orangeburg, NY area Start Date: ASAP!! Duration: 6+ Month Contract (possible Contract-to-Hire) Hours: Monday-Friday; 2nd Shift: 3pm-11:30pm Duties/Responsibilities: Maintains all production areas in a clean and orde...

    Date Posted: 12/11/2025 Recommended

  • EHS Specialist Coordinator

    Dallas, Texas

    Job Title: EHS Specialist Coordinator Location: Dallas, Texas Type: Contract, 3-6 Months Compensation: $49-52 hourly Contractor Work Model: Onsite Hours: 7am to 4pm CST, Monday to Friday. Candidates need to be flexible with shift hours, as they many ne...

    Date Posted: 11/24/2025 Recommended