This includes room release, line clearance, in-process batch record review or post-executed review ... Perform QA release and line clearance inspections, AQL checks on product. * Perform Label Control ...
This includes room release, line clearance, in-process batch record review or post-executed review ... Perform QA release and line clearance inspections, AQL checks on product. * Perform Label Control ...
Critically review and disposition batch record documentation for products manufactured by external third parties. * Perform the quality review of related cGMP documentation generated at third parties ...
Critically review and disposition batch record documentation for products manufactured by external third parties. * Perform the quality review of related cGMP documentation generated at third parties ...
Quality Assurance Manager
Alpharetta, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quick apply
Quality Assurance Manager
Alpharetta, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Alpharetta, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Alpharetta, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Chamblee, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Chamblee, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Chamblee, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quick apply
Quality Assurance Manager
Chamblee, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Alpharetta, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Assurance Manager
Alpharetta, GA · On-site
Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance * Develop and enforce ...
Quality Control Technician
Atlanta, GA · On-site
$18 - $23/hr
At least 1 year of Quality Assurance experience in the medical device industry . Key Skills * Product Testing * Batch Record (DHR) Review * GMP & GLP Compliance * SOP Documentation * Internal ...
Quality Control Technician
Atlanta, GA · On-site
$18 - $23/hr
At least 1 year of Quality Assurance experience in the medical device industry . Key Skills * Product Testing * Batch Record (DHR) Review * GMP & GLP Compliance * SOP Documentation * Internal ...
QA Technician
Mcdonough, GA · On-site
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
QA Technician
Mcdonough, GA · On-site
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Perform quality assurance review through verifying the received materials and required ... Observe temperature recording devices on storage units, (i.e. freezers) and perform required ...
Review Device Batch Record for completeness and GMP documentation * Release product in Epicor from ... Previous experience with medical device quality control * Detail oriented and organized * Own ...
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Review Device Batch Record for completeness and GMP documentation * Release product in Epicor from ... Previous experience with medical device quality control * Detail oriented and organized * Own ...
Review Device Batch Record for completeness and GMP documentation * Release product in Epicor from ... Previous experience with medical device quality control * Detail oriented and organized * Own ...
Quick apply
Review Device Batch Record for completeness and GMP documentation * Release product in Epicor from ... Previous experience with medical device quality control * Detail oriented and organized * Own ...
Monitor incoming concerns, online reviews, and operational requests, ensuring timely review ... Maintain organized, audit-ready records and documentation related to compliance, issue management ...
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Monitor incoming concerns, online reviews, and operational requests, ensuring timely review ... Maintain organized, audit-ready records and documentation related to compliance, issue management ...
Be Seen First
Quality Assurance (QA) Manager / Food Safety Manager
Atlanta, GA · On-site
$55K - $65K/yr
Distribution Records Supplier Quality Assurance * Approve suppliers. * Conduct supplier evaluations. * Maintain Approved Supplier Program. * Review food safety certifications. * Verify COAs.
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Be Seen First
Quality Assurance (QA) Manager / Food Safety Manager
Atlanta, GA · On-site
$55K - $65K/yr
Distribution Records Supplier Quality Assurance * Approve suppliers. * Conduct supplier evaluations. * Maintain Approved Supplier Program. * Review food safety certifications. * Verify COAs.
Quality Assurance Specialist
Atlanta, GA · On-site +1
Monitor incoming concerns, online reviews, and operational requests, ensuring timely review ... Maintain organized, audit-ready records and documentation related to compliance, issue management ...
Quality Assurance Specialist
Atlanta, GA · On-site +1
Monitor incoming concerns, online reviews, and operational requests, ensuring timely review ... Maintain organized, audit-ready records and documentation related to compliance, issue management ...
Areas of Focus Quality Assurance Technician focuses on dock audits and record inspection and test ... Review circuit tending paperwork Troubleshoot any conditions that adversely affect product quality ...
Areas of Focus Quality Assurance Technician focuses on dock audits and record inspection and test ... Review circuit tending paperwork Troubleshoot any conditions that adversely affect product quality ...
Areas of Focus Quality Assurance Technician focuses on dock audits and record inspection and test ... Review circuit tending paperwork • Troubleshoot any conditions that adversely affect product ...
Areas of Focus Quality Assurance Technician focuses on dock audits and record inspection and test ... Review circuit tending paperwork • Troubleshoot any conditions that adversely affect product ...
Areas of Focus Quality Assurance Technician focuses on dock audits and record inspection and test ... Review circuit tending paperwork • Troubleshoot any conditions that adversely affect product ...
Areas of Focus Quality Assurance Technician focuses on dock audits and record inspection and test ... Review circuit tending paperwork • Troubleshoot any conditions that adversely affect product ...
Quality Assurance Batch Record Review information
See Decatur, GA salary details
$12.67 - $17.03
17% of jobs
$18.46 is the 25th percentile. Wages below this are outliers.
$17.03 - $21.38
24% of jobs
The median wage is $23.55 / hr.
$21.38 - $25.73
18% of jobs
$25.73 - $30.08
15% of jobs
$30.45 is the 75th percentile. Wages above this are outliers.
$30.08 - $34.44
10% of jobs
$34.44 - $38.79
8% of jobs
$38.79 - $43.14
5% of jobs
$43.14 - $47.49
3% of jobs
$47.49 - $51.85
0% of jobs
$51.85 - $56.20
0% of jobs
$56.20 - $60.55
0% of jobs
$12
$28
$60
How much do quality assurance batch record review jobs pay per hour?
What are some common challenges faced during quality assurance batch record review, and how can they be managed?
What are the key skills and qualifications needed to thrive as a quality assurance batch record review specialist, and why are they important?
What is quality assurance batch record review?
What is the difference between Quality Assurance Batch Record Review vs Quality Control Inspector?
| Aspect | Quality Assurance Batch Record Review | Quality Control Inspector |
|---|---|---|
| Primary Focus | Reviewing and approving batch records for compliance and accuracy | Inspecting products and materials for quality and defects |
| Responsibilities | Ensuring batch documentation meets regulatory standards | Performing physical inspections and testing of products |
| Credentials | Typically requires QA certifications, GMP knowledge | Often requires quality control or lab certifications |
| Work Environment | Office-based review, documentation-focused | Manufacturing floor, lab testing environment |
While both roles ensure product quality, the Quality Assurance Batch Record Review focuses on document review and compliance, whereas the Quality Control Inspector conducts physical product inspections. Both are essential for maintaining quality standards in manufacturing industries.
Full-time
Re-posted 26 days ago
Job description
Position Overview
The Quality Inspector is primarily responsible for supporting activities on the production floor. This includes room release, line clearance, in-process batch record review or post-executed review to ensure proper good documentation practices are followed. Provide quality oversight to all production areas to ensure product quality and compliance to cGMPs. This person works closely with operations personnel ensuring cGMP concerns are identified and resolved appropriately. Must be available/flexible to work second or third shift and weekends.
Duties and Responsibilities
- Required to be on-the-floor and present to provide quality oversight for all critical manufacturing and packaging processes.
- Perform QA release and line clearance inspections, AQL checks on product.
- Perform Label Control functions (issuance and reconciliation).
- Perform testing of incoming printed labeling materials
- Conduct review of batch records.
- Perform sampling of the Purified Water System
- Identify deviations and ensure investigations are initiated by the appropriate personnel.
- Clearly communicate complex issues to Management personnel.
- Support creation / revision of SOPs to reflect current practices.
- Assist with FDA and other regulatory inspections.
- Perform all activities in compliance with Osmotica Quality System, site environmental, health and safety rules; and applicable FDA and international regulations.
- Maintain knowledge of current regulatory requirements pertaining to drug product manufacture.
- Perform additional duties and responsibilities as assigned.
Core Competencies
- Position requires the ability to work independently and effectively in all areas of communication, collaboration, and decision-making.
- Great attention to detail with ability to work on multiple projects.
- Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency.
- Collaborate with Production, Warehouse and other QA team members as partners.
- Computer experience required; Proficiency in Microsoft Office (Word, Excel).
Experience and Qualifications
- High School Diploma or equivalent or technical school certificate.
- Two years of experience in, or support of, pharmaceutical or biotech GMP manufacturing.
- Proficient knowledge of a GMP production facility, manufacturing processes, and/or inspection processes.
- Demonstrated understanding and application of cGMP, current industries practices and relevant guidance.
- Excellent written and verbal communication skills.
- Ability to multi-task effectively.
- Quality Assurance experience a plus.