Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line ...
Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line ...
Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line ...
Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line ...
Senior Quality Assurance Specialist
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
Brentwood, MO · On-site
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
Brentwood, MO · On-site
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
Brentwood, MO · On-site
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Senior Quality Assurance Specialist
Brentwood, MO · On-site
$77K - $106K/yr
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Packaging Documentation Specialist - MDI
Fall River, MA · On-site
$66K - $86K/yr
Reviews and approval of master batch records. * Develops appropriate disposition metrics, works ... Defends the validation programs and strategies to customers and regulatory auditors. * Performs ...
Packaging Documentation Specialist - MDI
Fall River, MA · On-site
$66K - $86K/yr
Reviews and approval of master batch records. * Develops appropriate disposition metrics, works ... Defends the validation programs and strategies to customers and regulatory auditors. * Performs ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Packaging Documentation Specialist - MDI
Fall River, MA · On-site
$66K - $86K/yr
Reviews and approval of master batch records. * Develops appropriate disposition metrics, works ... Defends the validation programs and strategies to customers and regulatory auditors. * Performs ...
Packaging Documentation Specialist - MDI
Fall River, MA · On-site
$66K - $86K/yr
Reviews and approval of master batch records. * Develops appropriate disposition metrics, works ... Defends the validation programs and strategies to customers and regulatory auditors. * Performs ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
Communicate issues identified during batch production or record reviews promptly to management ... Certified Quality Auditor (CQA) Certification preferred. PHYSICAL QUALIFICATIONS * Position ...
$66K - $86K/yr
Reviews and approval of master batch records. Develops appropriate disposition metrics, works with ... Defends the validation programs and strategies to customers and regulatory auditors. Performs ...
$66K - $86K/yr
Reviews and approval of master batch records. Develops appropriate disposition metrics, works with ... Defends the validation programs and strategies to customers and regulatory auditors. Performs ...
Quality Assurance Auditor - Pest Control and Environmental Monitoring Catalent's Winchester ... Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and ...
Quality Assurance Auditor - Pest Control and Environmental Monitoring Catalent's Winchester ... Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and ...
Quality Assurance Auditor - Pest Control and Environmental Monitoring About Site Catalent ... Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and ...
Quality Assurance Auditor - Pest Control and Environmental Monitoring About Site Catalent ... Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and ...
$16.25 - $20.75/hr
Key Skills Product Testing Batch Record (DHR) Review GMP & GLP Compliance SOP Documentation Internal Auditing Attention to Detail Documentation & Record Management Computer Skills Database software ...
$16.25 - $20.75/hr
Key Skills Product Testing Batch Record (DHR) Review GMP & GLP Compliance SOP Documentation Internal Auditing Attention to Detail Documentation & Record Management Computer Skills Database software ...
Quality Assurance Auditor - Pest Control and Environmental Monitoring About Site Catalent ... Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and ...
Quality Assurance Auditor - Pest Control and Environmental Monitoring About Site Catalent ... Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and ...
Quality Control Technician
Atlanta, GA · On-site
$18 - $23/hr
Batch Record (DHR) Review * GMP & GLP Compliance * SOP Documentation * Internal Auditing * Attention to Detail * Documentation & Record Management Computer Skills * Database software * Inventory ...
Quality Control Technician
Atlanta, GA · On-site
$18 - $23/hr
Batch Record (DHR) Review * GMP & GLP Compliance * SOP Documentation * Internal Auditing * Attention to Detail * Documentation & Record Management Computer Skills * Database software * Inventory ...
QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 330pm-2am)
Bedford, NH · On-site
Perform QA on-the-floor activities supporting client projects, including room release, auditing ... Batch record review for adherence to internal procedures and Good Documentation Practices * Support ...
QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 330pm-2am)
Bedford, NH · On-site
Perform QA on-the-floor activities supporting client projects, including room release, auditing ... Batch record review for adherence to internal procedures and Good Documentation Practices * Support ...
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Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $80K/yr (+ commission)
Review batch records and oversee documentation accuracy and completeness * Coordinate deviation ... Act as a technical resource and mentor for QA Technicians Auditing & Inspection Readiness
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Be Seen First
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $80K/yr (+ commission)
Review batch records and oversee documentation accuracy and completeness * Coordinate deviation ... Act as a technical resource and mentor for QA Technicians Auditing & Inspection Readiness
Batch Record Auditor information
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$17.24 is the 25th percentile. Wages below this are outliers.
$12.74 - $24.61
66% of jobs
$30.71 is the 75th percentile. Wages above this are outliers.
$24.61 - $36.47
18% of jobs
$36.47 - $48.34
6% of jobs
$48.34 - $60.21
2% of jobs
$60.21 - $72.07
1% of jobs
$72.07 - $83.94
0% of jobs
$83.94 - $95.80
0% of jobs
$95.80 - $107.67
0% of jobs
$107.67 - $119.54
0% of jobs
$119.54 - $131.40
3% of jobs
$131.40 - $143.27
4% of jobs
$12
$38
$143
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Manufacturing Quality Assurance Specialist II - 2nd Shift
Lexington, KY
Other
Re-posted 13 hours ago
Kindeva rating
6.7
Based on 9 frontline employees who took The Breakroom Quiz
Job description
Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: Responsible for on-shift support of manufacturing operations, providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing. Also responsible for review of controlled Current Good Manufacturing Practices (cGMP) documentation and manufacturing records, including any deviations or Out-of-Specification (OOS) results that may have occurred during lot production. Participates in the release of raw materials, intermediates, and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities, and keeps management informed on quality issues.
Responsibilities:
- Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line clearances.
- Supports the development and maintenance of Quality Systems as appropriate.
- Leads continuous improvement objectives to assure compliance with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations.
- Advises senior management on findings and recommendations related to internal and external auditing.
- Manages deviation, Out-of-Specification (OOS), Corrective and Preventive Action (CAPA), and Change Control Systems.
- Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards. Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
- Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
- Reviews and approves cGMP documentation, including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
- Develops and maintains metrics and trending reports for Compliance-related activities.Job Details
About Kindeva
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Industry
Pharmaceutical and medicine manufacturing and medical equipment and supplies manufacturing