The individual manages and enhances electronic quality systems (eQMS), including TrackWise, supports cross-functional collaboration for investigation and documentation activities, and leads ...
The individual manages and enhances electronic quality systems (eQMS), including TrackWise, supports cross-functional collaboration for investigation and documentation activities, and leads ...
Sr. Compliance Associate
Billerica, MA · On-site
The individual manages and enhances electronic quality systems (eQMS), including TrackWise, supports cross-functional collaboration for investigation and documentation activities, and leads ...
Sr. Compliance Associate
Billerica, MA · On-site
The individual manages and enhances electronic quality systems (eQMS), including TrackWise, supports cross-functional collaboration for investigation and documentation activities, and leads ...
Sales Quality Engineer
Wilmington, MA · On-site
$78K - $101K/yr
Ensure timely and accurate recording of all non-conformance issues into the Integrated Management System and TrackWise. * Lead and coordinate CAPA activities, ensuring actions are linked directly to ...
Sales Quality Engineer
Wilmington, MA · On-site
$78K - $101K/yr
Ensure timely and accurate recording of all non-conformance issues into the Integrated Management System and TrackWise. * Lead and coordinate CAPA activities, ensuring actions are linked directly to ...
Sales Quality Engineer
Wilmington, MA · On-site
$78K - $101K/yr
Ensure timely and accurate recording of all non-conformance issues into the Integrated Management System and TrackWise. * Lead and coordinate CAPA activities, ensuring actions are linked directly to ...
Sales Quality Engineer
Wilmington, MA · On-site
$78K - $101K/yr
Ensure timely and accurate recording of all non-conformance issues into the Integrated Management System and TrackWise. * Lead and coordinate CAPA activities, ensuring actions are linked directly to ...
Provide ongoing administration and support for the TrackWise training system Maintain curricula by processing changes to training requirements and curricula in support of Quality and Supply Chain ...
Provide ongoing administration and support for the TrackWise training system Maintain curricula by processing changes to training requirements and curricula in support of Quality and Supply Chain ...
Sr. Quality Assurance Specialist
$92K - $127K/yr
... TrackWise, ability to learn additional software applications as the need arises. Strong written and oral communication skills required. Looking for someone who is willing to learn and eager to get ...
Sr. Quality Assurance Specialist
$92K - $127K/yr
... TrackWise, ability to learn additional software applications as the need arises. Strong written and oral communication skills required. Looking for someone who is willing to learn and eager to get ...
Experience with TrackWise. Experience with Medical Device, Small Molecules and other pharmaceutical technologies Qualifications Bachelor's degree in chemistry, biology or a related discipline Minimum ...
Experience with TrackWise. Experience with Medical Device, Small Molecules and other pharmaceutical technologies Qualifications Bachelor's degree in chemistry, biology or a related discipline Minimum ...
Experience with TrackWise. Experience with Medical Device, Small Molecules and other pharmaceutical technologies Qualifications Minimum 5 years Quality Assurance experience supporting the manufacture ...
Experience with TrackWise. Experience with Medical Device, Small Molecules and other pharmaceutical technologies Qualifications Minimum 5 years Quality Assurance experience supporting the manufacture ...
Experience with electronic Quality Management Systems (e.g., Veeva, TrackWise) * Up to 30% travel required.
Experience with electronic Quality Management Systems (e.g., Veeva, TrackWise) * Up to 30% travel required.
Past experience working with QC instrumentation, Labware, Trackwise, and/or Documentum in the pharma/biopharmaceutical field is preferred but not required. Additional Information $30/hr 18 MONTHS
Past experience working with QC instrumentation, Labware, Trackwise, and/or Documentum in the pharma/biopharmaceutical field is preferred but not required. Additional Information $30/hr 18 MONTHS
Candidate must have expertise in Trackwise and Mastercontrol. Bachelor's degree is required-preferably in science field. Pharma/BIO experience preferred Very Junior level role-1-3 years is great.
Candidate must have expertise in Trackwise and Mastercontrol. Bachelor's degree is required-preferably in science field. Pharma/BIO experience preferred Very Junior level role-1-3 years is great.
... TrackWise, ability to learn additional software applications as the need arises. Strong written and oral communication skills required. Additional Information Kind Regards Nisha Dwivedi Clinical ...
... TrackWise, ability to learn additional software applications as the need arises. Strong written and oral communication skills required. Additional Information Kind Regards Nisha Dwivedi Clinical ...
Serve as a subject matter resource for the eDMS (Trackwise Digital) used to manage controlled documents and associated workflows. * Provide project and validation support for activities involving ...
Serve as a subject matter resource for the eDMS (Trackwise Digital) used to manage controlled documents and associated workflows. * Provide project and validation support for activities involving ...
Serve as a subject matter resource for the eDMS (Trackwise Digital) used to manage controlled documents and associated workflows. * Provide project and validation support for activities involving ...
Serve as a subject matter resource for the eDMS (Trackwise Digital) used to manage controlled documents and associated workflows. * Provide project and validation support for activities involving ...
CSV Specialist
Lexington, MA · On-site
$45 - $52/hr
Experience with TrackWise, Veeva, Kneat, ALM, or similar documentation systems. * Familiarity with MODA, LabWare, or other QC/LIMS platforms preferred. * Proficient in Microsoft Teams and electronic ...
CSV Specialist
Lexington, MA · On-site
$45 - $52/hr
Experience with TrackWise, Veeva, Kneat, ALM, or similar documentation systems. * Familiarity with MODA, LabWare, or other QC/LIMS platforms preferred. * Proficient in Microsoft Teams and electronic ...
North America Service Quality Specialist
$71K - $107K/yr
Act as the site lead user for eQMS systems including TrackWise/Falcon eQMS, HR4You Learning, and ManGo electronic documentation system * Manage all documentation and records of the organization ...
North America Service Quality Specialist
$71K - $107K/yr
Act as the site lead user for eQMS systems including TrackWise/Falcon eQMS, HR4You Learning, and ManGo electronic documentation system * Manage all documentation and records of the organization ...
North America Service Quality Specialist
Burlington, MA · On-site
$71K - $107K/yr
Act as the site lead user for eQMS systems including TrackWise/Falcon eQMS, HR4You Learning, and ManGo electronic documentation system * Manage all documentation and records of the organization ...
North America Service Quality Specialist
Burlington, MA · On-site
$71K - $107K/yr
Act as the site lead user for eQMS systems including TrackWise/Falcon eQMS, HR4You Learning, and ManGo electronic documentation system * Manage all documentation and records of the organization ...
Experience with TrackWise. Ability to learn additional software applications as the need arises. Strong written and oral communication skills required. Experience in Root Cause Analysis techniques.
Experience with TrackWise. Ability to learn additional software applications as the need arises. Strong written and oral communication skills required. Experience in Root Cause Analysis techniques.
... TrackWise - SABA 50%- Supporting 400/300-LTP Training 50%- Supporting 205-ABP Training Additional Information Regards, Sweta Verma IT Recruiter Integrated Resources, Inc. Inc. 5000 - 2007-2014 (8th ...
... TrackWise - SABA 50%- Supporting 400/300-LTP Training 50%- Supporting 205-ABP Training Additional Information Regards, Sweta Verma IT Recruiter Integrated Resources, Inc. Inc. 5000 - 2007-2014 (8th ...
QC Microbiologist
$25.75 - $34/hr
... Experience with Trackwise/LIMS preferred Qualifications Experience with LIMS BS/MS or technology related science discipline with equivalent experience Knowledge of SOP preferred Additional ...
QC Microbiologist
$25.75 - $34/hr
... Experience with Trackwise/LIMS preferred Qualifications Experience with LIMS BS/MS or technology related science discipline with equivalent experience Knowledge of SOP preferred Additional ...
Trackwise information
See Boston, MA salary details
$5.7K is the 25th percentile. Wages below this are outliers.
$5.3K - $6.2K
54% of jobs
$6.2K - $7K
0% of jobs
$7K - $7.8K
0% of jobs
$7.8K - $8.7K
0% of jobs
$8.7K - $9.5K
0% of jobs
$9.5K - $10.4K
0% of jobs
$10.4K - $11.2K
0% of jobs
$11.2K - $12K
2% of jobs
$12K - $12.9K
14% of jobs
$13.1K is the 75th percentile. Wages above this are outliers.
$12.9K - $13.7K
15% of jobs
$13.7K - $14.5K
14% of jobs
$5.3K
$9.5K
$14.5K
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.
- Quality Assurance
- Quality Assurance Biotech
- Remote Pharmaceutical Quality Assurance
- Pharmaceutical Quality Assurance Associate
- Internship Quality Assurance Biotech
- Insurance Quality Assurance
- Pharmaceutical Quality Assurance Specialist
- Contract Qa
- Part Time Remote Pharmaceutical Quality Assurance
- Part Time Quality Assurance

Job description
Job Summary
The Sr. Associate, Compliance is responsible for overseeing vendor management and ensuring supplier quality compliance, while also providing scientific and technical support for quality investigations, including OOS, OOT, and product quality complaints. This role drives effective root cause analysis, timely closure of investigations, and adherence to GLP, cGMP, and Quality Management System (QMS) standards. The individual manages and enhances electronic quality systems (eQMS), including TrackWise, supports cross-functional collaboration for investigation and documentation activities, and leads initiatives to improve QMS efficiency and compliance. Additionally, the role includes analyzing quality data and trends, preparing Annual Product Quality Reviews (APQRs), and presenting quality metrics and risk assessments to support continuous improvement and informed decision-making.
Area Of Responsibility
- Review and assess vendor SCAR (Supplier Corrective Action Reports) and ensure effective follow-up.
- Ensure vendor-supplied products comply with regulatory and quality standards.
- Develop and maintain strong, long-term relationships with approved vendors.
- Evaluate new vendor capabilities, conduct onboarding interviews, and communicate expectations and compliance requirements.
- Establish performance standards and continuously evaluate vendor performance.
- Identify opportunities to enhance and optimize vendor management programs.
- Support vendor selection initiatives to ensure engagement with qualified and compliant suppliers.
- Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Work directly on technical investigations relating to Product Quality Complaints
- Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
- Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
- Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
- Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
- Manage electronic Quality Management System (TrackWise)
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
- Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
- Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.Â
- Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
- Author/revise standard operating procedures (SOPs) and test methods, as required
- Other duties as assigned
About Sun Pharmaceutical Industries
Sourced by ZipRecruiter
Industry
Pharmaceutical product wholesalers
Company size
10,000+ Employees
Headquarters location
Princeton, NJ, US