Ability to use enterprise software (i.e., JDE, Trackwise, etc.) * Ability to qualify for Grade C areas Physical / safety requirements: * Duties may require overtime work, including nights and ...
Ability to use enterprise software (i.e., JDE, Trackwise, etc.) * Ability to qualify for Grade C areas Physical / safety requirements: * Duties may require overtime work, including nights and ...
Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.) Physical / Safety Requirements: * Require overtime work on occasion, including nights and weekends * Use of hands and ...
Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.) Physical / Safety Requirements: * Require overtime work on occasion, including nights and weekends * Use of hands and ...
Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.) * Critical thinking and problem-solving skills * High initiative and ability to deal with ambiguity
Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.) * Critical thinking and problem-solving skills * High initiative and ability to deal with ambiguity
JDE, BPLM, Pilgrim, Trackwise, etc.) * Knowledge of instrument/software/documentation repair and calibration systems preferred Physical / safety requirements: * Must be able to wear personal ...
JDE, BPLM, Pilgrim, Trackwise, etc.) * Knowledge of instrument/software/documentation repair and calibration systems preferred Physical / safety requirements: * Must be able to wear personal ...
JDE, BPLM, Trackwise, etc.) * Manages time effectively and independently within assigned responsibilities * Ability to prioritize multiple projects/workflows and manage time efficiently in order to ...
JDE, BPLM, Trackwise, etc.) * Manages time effectively and independently within assigned responsibilities * Ability to prioritize multiple projects/workflows and manage time efficiently in order to ...
Ability to use enterprise software (i.e., JDE, Trackwise, etc.) * Ability to qualify for Grade C areas Physical / safety requirements: * Duties may require overtime work, including nights and ...
Ability to use enterprise software (i.e., JDE, Trackwise, etc.) * Ability to qualify for Grade C areas Physical / safety requirements: * Duties may require overtime work, including nights and ...
Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.) Physical / Safety Requirements: * Require overtime work on occasion, including nights and weekends * Use of hands and ...
Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.) Physical / Safety Requirements: * Require overtime work on occasion, including nights and weekends * Use of hands and ...
Warehouse Coordinator (1st Shift)
Bloomington, IN · On-site
$16.75 - $21.25/hr
Ability to use enterprise systems (e.g., D365, Veeva, Trackwise). Physical / safety requirements: * Ability to lift up to 50 lbs. * Able to bend, twist, stoop, and lift regularly. * Must work ...
Warehouse Coordinator (1st Shift)
Bloomington, IN · On-site
$16.75 - $21.25/hr
Ability to use enterprise systems (e.g., D365, Veeva, Trackwise). Physical / safety requirements: * Ability to lift up to 50 lbs. * Able to bend, twist, stoop, and lift regularly. * Must work ...
Quality Client Representative
Bloomington, IN · On-site
$19 - $23/hr
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements: * Duties may require overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is ...
Quality Client Representative
Bloomington, IN · On-site
$19 - $23/hr
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements: * Duties may require overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is ...
JDE, BPLM, Pilgrim, Trackwise, etc.) * Self-directed with high initiative and ownership * Critical thinking, creative thinking, and problem solving skills Physical / Safety Requirements: * Ability to ...
JDE, BPLM, Pilgrim, Trackwise, etc.) * Self-directed with high initiative and ownership * Critical thinking, creative thinking, and problem solving skills Physical / Safety Requirements: * Ability to ...
Warehouse Coordinator (1st Shift)
Bloomington, IN · On-site
$16.75 - $21.25/hr
Ability to use enterprise systems (e.g., D365, Veeva, Trackwise). Physical / safety requirements: * Ability to lift up to 50 lbs. * Able to bend, twist, stoop, and lift regularly. * Must work ...
Warehouse Coordinator (1st Shift)
Bloomington, IN · On-site
$16.75 - $21.25/hr
Ability to use enterprise systems (e.g., D365, Veeva, Trackwise). Physical / safety requirements: * Ability to lift up to 50 lbs. * Able to bend, twist, stoop, and lift regularly. * Must work ...
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements * Duties may require overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is ...
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements * Duties may require overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is ...
Manufacturing QMS Consultant_Pharma/Life Sciences & Med Device_Director
Indianapolis, IN · On-site
$155K - $410K/yr
Experience with Quality IT systems (eQMS, Veeva, Trackwise, etc.).Knowledgeable in business processes in quality roles, manufacturing, or lab operations.Key experience: (e.g., process engineering ...
Manufacturing QMS Consultant_Pharma/Life Sciences & Med Device_Director
Indianapolis, IN · On-site
$155K - $410K/yr
Experience with Quality IT systems (eQMS, Veeva, Trackwise, etc.).Knowledgeable in business processes in quality roles, manufacturing, or lab operations.Key experience: (e.g., process engineering ...
Packaging Validation Associate I - 1st Shift
Bloomington, IN · On-site
$14 - $17/hr
JDE, BPLM, Trackwise, etc.) * Manages time effectively and independently within assigned responsibilities * Ability to prioritize multiple projects/workflows and manage time efficiently in order to ...
Packaging Validation Associate I - 1st Shift
Bloomington, IN · On-site
$14 - $17/hr
JDE, BPLM, Trackwise, etc.) * Manages time effectively and independently within assigned responsibilities * Ability to prioritize multiple projects/workflows and manage time efficiently in order to ...
Maintenance Technician
Bloomington, IN · On-site
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements: • Must be able to lift, push/pull, and carry up to 50 pounds • May be required to stand for over 4 hours per day • Must be ...
Maintenance Technician
Bloomington, IN · On-site
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements: • Must be able to lift, push/pull, and carry up to 50 pounds • May be required to stand for over 4 hours per day • Must be ...
JDE, BPLM, Pilgrim, Trackwise, etc.) * Knowledge of instrument/software/documentation repair and calibration systems preferred Physical / safety requirements: * Must be able to wear personal ...
JDE, BPLM, Pilgrim, Trackwise, etc.) * Knowledge of instrument/software/documentation repair and calibration systems preferred Physical / safety requirements: * Must be able to wear personal ...
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements * Duties may require overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is ...
JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements * Duties may require overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is ...
CAPA Manager
Bloomington, IN · On-site
Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions ...
CAPA Manager
Bloomington, IN · On-site
Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions ...
Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.) * Critical thinking and problem-solving skills * High initiative and ability to deal with ambiguity
Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.) * Critical thinking and problem-solving skills * High initiative and ability to deal with ambiguity
Experience with Veeva, TrackWise, or similar quality systems Technical Skills * Complaint Investigations * Root Cause Analysis (RCA) * CAPA Management * Technical Writing * Batch Record Review * GMP ...
Quick apply
Experience with Veeva, TrackWise, or similar quality systems Technical Skills * Complaint Investigations * Root Cause Analysis (RCA) * CAPA Management * Technical Writing * Batch Record Review * GMP ...
Trackwise information
See Indiana salary details
$5K is the 25th percentile. Wages below this are outliers.
$4.7K - $5.4K
54% of jobs
$5.4K - $6.1K
0% of jobs
$6.1K - $6.9K
0% of jobs
$6.9K - $7.6K
0% of jobs
$7.6K - $8.3K
0% of jobs
$8.3K - $9.1K
0% of jobs
$9.1K - $9.8K
0% of jobs
$9.8K - $10.5K
2% of jobs
$10.5K - $11.3K
14% of jobs
$11.5K is the 75th percentile. Wages above this are outliers.
$11.3K - $12K
15% of jobs
$12K - $12.7K
14% of jobs
$4.7K
$8.3K
$12.7K
How much do trackwise jobs pay per month?
What is the highest paid logistics job?
What jobs pay 4000 a week without a degree?
What is the 3 month rule for jobs?
What does TrackWise do?
What is a TrackWise job?
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 are the typical daily responsibilities of a TrackWise Specialist?
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, and why are they important?
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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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 24 days ago
Job description
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.
This role:
The Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.
The responsibilities:
- Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
- Review and release commercial batch records to production for execution
- Train manufacturing personnel on new and/or significant changes to MBRs
- Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)
- Authors technical studies in support of investigations or process improvements
- Own change controls and associated tasks
- Approve project related Bill of Materials
- Commercial contact for assigned internal and external clients
- Manages client project updates and reviews with all levels of management
- Participate (with assistance) in Business Review Meetings
- Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information
- Participate on client calls and on-site visits to discuss projects and issue resolutions
- Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
- Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria
- Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
- Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product
Required qualifications:
- BS degree, preferably in a science-related field
- Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
- Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
- Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
- Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
- Ability to use enterprise software (i.e., JDE, Trackwise, etc.)
- Ability to qualify for Grade C areas
Physical / safety requirements:
- Duties may require overtime work, including nights and weekends
- Position may require sitting or standing for long periods of time
- Ability to qualify for Grade C areas
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
- 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/