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Trackwise Jobs in Indiana (NOW HIRING)

CBRE

Laboratory Quality Specialist

Indianapolis, IN · On-site

Trackwise Change controls and deviations owner, responsible for investigations and ensuring the Change Control and/or Deviation is accurately documented. * Ensure IQ/OQ/PQ protocols completed by CBRE ...

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How much do trackwise jobs pay per month?

As of Sep 8, 2026, the average monthly pay for trackwise in Indiana is $8,308.92, according to ZipRecruiter salary data. Most workers in this role earn between $4,958.33 and $11,658.33 per month, depending on experience, location, and employer.

What is a Trackwise?

A TrackWise job typically involves working with TrackWise, a quality management system (QMS) used in regulated industries like pharmaceuticals, medical devices, and biotechnology. Professionals in these roles manage and configure TrackWise to streamline quality processes such as deviations, CAPA, audits, and complaints. Responsibilities may include system administration, troubleshooting, validation, and ensuring compliance with regulatory standards. Strong knowledge of TrackWise configuration, workflows, and reporting is often required.

What does a Trackwise specialist do?

As a TrackWise Specialist, your typical day involves configuring and maintaining the TrackWise quality management system, resolving user issues, and supporting key functions such as CAPA, document management, and audit tracking. You will regularly collaborate with quality assurance, IT, and operations teams to ensure system alignment with company processes and regulatory requirements. Additionally, you may train end-users, generate reports, and participate in system upgrades or process improvement initiatives. This role requires strong attention to detail and excellent communication skills to ensure accurate data management and continuous quality improvement.

What are the key skills and qualifications needed to thrive in the Trackwise position?

To thrive as a TrackWise Specialist, you need a strong foundation in quality management systems (QMS), regulatory compliance knowledge, and experience in data analysis, typically supported by a degree in life sciences, engineering, or a related field. Proficiency in the TrackWise QMS software, as well as familiarity with document control, CAPA, and audit management modules, is essential, and TrackWise certification is highly regarded. Strong problem-solving, attention to detail, and effective communication skills are key soft skills for collaborating with cross-functional teams and troubleshooting system issues. These competencies are critical to maintaining regulatory compliance, optimizing workflow efficiency, and ensuring the successful implementation and support of TrackWise solutions in an organization.

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What job categories do people searching Trackwise jobs in Indiana look for?

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Trackwise jobs near you
Infographic showing various Trackwise job openings in Indiana as of August 2026, with employment types broken down into 89% Full Time, 10% Contract, and 1% Nights. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution, with an average salary of $99,707 per year, or $47.9 per hour.

Manufacturing Supervisor, 3rd Shift

Simtra BioPharma Solutions

Bloomington, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra?Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
The role:
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in manufacturing of sterile injectable drug products.
Hours: Monday - Thursday
The Supervisor, Aseptic Operations provides decision making and oversight to ensure compliance to all standard operating procedures and batch records. They must communicate effectively with Operations support departments (Quality, Technical Services, Engineering & Maintenance, etc.), multiple levels of management, and other customer support departments. The Supervisor, Aseptic Operations builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
Its responsibilities:
  • Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
  • Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
  • Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
  • Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities in order to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
  • Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
  • Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
  • Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
  • Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
  • Resolve technical, material and cGMP problems that may impact project deadlines.
  • Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
  • Obtain qualification to perform select critical operation processes.
  • Represent the company during audits and inspections.

Desirable qualifications:
  • Bachelor's Degree in a science, engineering, or business discipline strongly preferred
  • High School diploma or GED required
  • Minimum 2 years of manufacturing or operations support experience required
  • Minimum 1 year leadership experience required
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, PowerBI, Trackwise, etc.)

Physical / safety requirements:
  • Ability to stand or sit for extended periods of time
  • Ability to lift up to 50 pounds
  • Ability to push/pull heavy wheeled objects (i.e.: tanks, carts, pallet jacks, etc.)
  • Must be able to perform overhead work (i.e.: sanitizing walls and ceilings)
  • Physical coordination/flexibility to allow gowning for clean room environments
  • Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
  • Dexterity and physical condition to perform some level of repetitive motion tasks
  • Ability to wear respirator usage when product or task requires
  • Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
  • Use of hands and fingers to manipulate office equipment is required
  • Must be able to gown qualify for Grade A/B areas (filling)

In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

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