Perform QA Batch Review and Approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition to meet ...
Perform QA Batch Review and Approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition to meet ...
Perform QA Batch Review and Approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition to meet ...
Perform QA Batch Review and Approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition to meet ...
The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor is responsible for fostering strong client quality ...
The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor is responsible for fostering strong client quality ...
PR · On-site
The Specialist, Quality Assurance is responsible for QA batch record review and disposition ... The batch record review encompasses manufactured batch records, investigation of deviations ...
QA Batch Review and Product Release ... Review executed batch records for completeness, accuracy and compliance with approved procedures ...
QA Batch Review and Product Release ... Review executed batch records for completeness, accuracy and compliance with approved procedures ...
Senior Specialist, Field Quality QA Operations
$91K - $126K/yr
The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs ...
Senior Specialist, Field Quality QA Operations
$91K - $126K/yr
The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs ...
Quality Assurance Manager
$27 - $32/hr
In addition to batch record review and documentation control, the QA Specialist will contribute to deviation writing, investigation reporting, and continuous improvement initiatives. The ideal ...
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Quality Assurance Manager
$27 - $32/hr
In addition to batch record review and documentation control, the QA Specialist will contribute to deviation writing, investigation reporting, and continuous improvement initiatives. The ideal ...
Our Client is looking for Quality Assurance Technician Summary: Accountable for activities involved ... Responsibilities: Support Manufacturing batch record review activities. Prepare and issue ...
Our Client is looking for Quality Assurance Technician Summary: Accountable for activities involved ... Responsibilities: Support Manufacturing batch record review activities. Prepare and issue ...
Review executed batch production and packaging records for accuracy, completeness, and cGMP ... Identify and document errors, discrepancies, and deviations in batch records; escalate issues to QA ...
Review executed batch production and packaging records for accuracy, completeness, and cGMP ... Identify and document errors, discrepancies, and deviations in batch records; escalate issues to QA ...
Quality Assurance
Boca Raton, FL · On-site
$55/hr
In-Process Quality Assurance Specialist Time: 7am-7pm or 7pm-7am Salary: $55/ $69k Responsibilities ... Reviewed and prepared Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure ...
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Quality Assurance
Boca Raton, FL · On-site
$55/hr
In-Process Quality Assurance Specialist Time: 7am-7pm or 7pm-7am Salary: $55/ $69k Responsibilities ... Reviewed and prepared Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure ...
Batch Record Data Reviewer
Rensselaer, NY · On-site
Batch Record Data Reviewer Location: Rensselaer, NY (On-site) Job Summary: We are seeking an ... Escalate review findings and compliance concerns to QA, Manufacturing, QC, and Investigation teams.
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Batch Record Data Reviewer
Rensselaer, NY · On-site
Batch Record Data Reviewer Location: Rensselaer, NY (On-site) Job Summary: We are seeking an ... Escalate review findings and compliance concerns to QA, Manufacturing, QC, and Investigation teams.
Batch Record Reviewer
Allendale, NJ · On-site
$19 - $22/hr
Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...
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Batch Record Reviewer
Allendale, NJ · On-site
$19 - $22/hr
Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...
Experience with batch record review and batch record maintenance. * Knowledge of cGMP principles and quality assurance practices. * Ability to perform QA tests, QA checks, and QA documentation tasks ...
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Experience with batch record review and batch record maintenance. * Knowledge of cGMP principles and quality assurance practices. * Ability to perform QA tests, QA checks, and QA documentation tasks ...
Batch Record Specialist
Bloomington, IN · On-site
The ideal candidate will possess strong batch record review experience, a solid understanding of parenteral manufacturing processes, and the ability to collaborate with Operations, Quality, and ...
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Batch Record Specialist
Bloomington, IN · On-site
The ideal candidate will possess strong batch record review experience, a solid understanding of parenteral manufacturing processes, and the ability to collaborate with Operations, Quality, and ...
Perform on-the-floor compliance review on executed records including batch records, equipment ... Support QA Raw Material group with release of raw materials * Able to react to change productively ...
Perform on-the-floor compliance review on executed records including batch records, equipment ... Support QA Raw Material group with release of raw materials * Able to react to change productively ...
Perform on-the-floor compliance review on executed records including batch records, equipment ... Support QA Raw Material group with release of raw materials * Able to react to change productively ...
Perform on-the-floor compliance review on executed records including batch records, equipment ... Support QA Raw Material group with release of raw materials * Able to react to change productively ...
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Execute batch record review and document deficiencies in a computerized system * Identify ...
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Execute batch record review and document deficiencies in a computerized system * Identify ...
Quality Assurance Tech II
Saint Louis, MO · On-site
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Execute batch record review and document deficiencies in a computerized system * Identify ...
Quality Assurance Tech II
Saint Louis, MO · On-site
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Execute batch record review and document deficiencies in a computerized system * Identify ...
Batch Record Reviewer
Allendale, NJ · On-site
$19 - $22/hr
Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...
Batch Record Reviewer
Allendale, NJ · On-site
$19 - $22/hr
Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...
Batch Record Reviewer
Allendale, NJ · On-site
$19 - $22/hr
Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...
Batch Record Reviewer
Allendale, NJ · On-site
$19 - $22/hr
Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...
Entry Level Qa Batch Record Review information
See salary details
$12.98 - $17.44
17% of jobs
$18.91 is the 25th percentile. Wages below this are outliers.
$17.44 - $21.90
24% of jobs
The median wage is $24.13 / hr.
$21.90 - $26.35
18% of jobs
$26.35 - $30.81
15% of jobs
$31.18 is the 75th percentile. Wages above this are outliers.
$30.81 - $35.27
10% of jobs
$35.27 - $39.73
8% of jobs
$39.73 - $44.19
5% of jobs
$44.19 - $48.65
3% of jobs
$48.65 - $53.10
0% of jobs
$53.10 - $57.56
0% of jobs
$57.56 - $62.02
0% of jobs
$12
$29
$62
How much do entry level qa batch record review jobs pay per hour?

Quality Associate, Batch Record Review and Product Disposition
San Diego, CA • On-site
Full-time
Medical, Life, Retirement, PTO
Re-posted 11 days ago
Job description
107100 Quality
Location:
San Diego
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
The Quality Associate supports Quality Operations through the Quality oversight of Manufacturing, Packaging, and Labeling Operations Batch Record Review, Product Disposition, Clinical and Commercial Supplier Management Oversight, quality records management, and GxP Metrics reporting. This position supports completion of Inspection Readiness Action Items and provides compliance support for the quality systems at Travere Therapeutics, Inc. and key suppliers. This position also supports continual process improvement for Quality Management Systems.
Primary Responsibilities:
- Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
- Perform QA Batch Review and Approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition to meet clinical and commercial production timelines
- Collaborate closely with Technical Operations and Clinical Operations Personnel responsible for Manufacturing, Labeling, Packaging, Batch Kitting, and Distribution
- Support QA Supplier Management and Oversight of Contract Manufacturing Organizations (CMOs) starting with Phase 2 Clinical Trials through marketed products, and in all situations where GMP Batches are required
- Manage assigned SOPs revisions and quality records (CAPAs, Deviations, Investigations, Product Complaints, Audit Responses, Change Controls, & Trainings) to ensure timely completion for the organization and associated department(s)
- Participates in supplier meetings, managing production timelines with batch release activities
- Support products for clinical development and commercial production including Oral Drugs, Biologics, and Combination Products
- Provides daily oversight of quality systems records including, CAPAs, Deviations, Investigations, Batch Record Review, and Change Controls
- Support revision of the existing SOP(s) and Work Instructions related to assigned duties to help define a clear and accurate process
Additional Responsibilities:
- Support audit program activities for internal, external, mock, and regulatory audits
- Provide quality and compliance oversight and act as a SME for the Quality Systems at Travere including, but not limited to:
- Veeva Quality Vault (QualityDocs and QMS)
- Document Management
- Quality Events (Complaints, Deviations, Audit Findings, Change Controls)
- Quality Actions (Audits, CAPAs, Effectiveness Checks, Investigations, Root Causes)
- Quality Metrics
- Ensure documentation in support of regulatory submissions is uploaded in QualityDocs appropriately
- Oversee the creation, revision, review, and approval of GxP controlled documents (e.g., SOPs, WINs, Forms) and records
- Additional duties assigned as needed
Education/Experience Requirements:
- Minimum of 2-3 years of experience in QA batch record review and leading QA oversight of Contract Manufacturing Organizations (CMOs)
- Quality Assurance (QA) experience with Manufacturing, Laboratories, Logistics, CMOs, Distributors, and Warehouses is preferred
Additional Skills/Experience:
- The ideal candidate will embody Travere's core values: Patient Inspired, Promoting Community, Courageous, and Stronger Together
- Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
- Preference for candidates familiar and experienced with electronic document management systems and QMS such as Veeva or similar
- Strong professional experience in a similar role within the pharmaceutical industry, providing supplier management support for pharmaceutical, medical device, or combination products
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional environment
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
- Prefer but not required: Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, implement improvements, and respond to situations affecting staff
- Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity
- Successful record of creating and managing complex project plans, timelines, budgets, and critical paths
- Ability to adapt to changes to priorities, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Experience with regulatory inspections
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote
- Ability to travel 10-20% domestically and internationally
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$85,000.00 - $105,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
About Travere Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
San Diego, CA, US
Year founded
2011