BioSpace
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Location: Las Vegas, NV
Minimum Requirements
COMPREHENSIVE KNOWLEDGE OF cGMPs AND THE ABILITY TO CORRECTLY INTERPRET MINIMUM STANDARDS.
EXPERIENCE WITH DOCUMENTATION SYSTEMS AND WITH DOCUMENT REVIEW AND AUDITING RESPONSIBILITIES.
WORKING KNOWLEDGE IN QUALITY SCIENCES, STATISTICS, AND COMPUTER-BASED OPERATIONS.
Job Description
MANAGES THE DEVELOPMENT, IMPLEMENTATION AND MAINTENANCE OF QA SYSTEMS AND ACTIVITIES.
MANAGES GENERATION AND REVIEW OF DOCUMENTS USED IN GOOD MANUFACTURING PRACTICES.
MANAGES AUDITS OF PRODUCTION AND QUALITY CONTROL AREAS.
Participates in internal audits, customer audits or regulatory audits.
May audit raw material vendors and prepare assessments.
Conducts site and remote audits based on regulations such as GMP (21CFR 210/211/11) or ISO standards (ISO 9001, 13485:2016).
Ensures manufacturing documentation supports updated filing requirements.
Reviews batch records, cleaning records, environmental monitoring records.
Leads investigations and resolves potential product quality issues.
Investigates nonconformities and establishes root cause analysis (RCA).
Handles deviations and CAPAs, applying corrective and preventative actions.
Manages out-of-specification/out-of-acceptable-tolerance (OOS/OOT) laboratory results.
Addresses supplier complaints (SCAR) and environmental excursions.
Develops schedules and performance standards for QA activities.
Conducts briefings and technical meetings with management and customer representatives.
Writes and reviews SOPs, protocols, and reports for ANDA filings.
Conducts laboratory deviation investigations and maintains laboratory standards.
Leads continuous improvement initiatives, focusing on release time, error rates, and equipment reliability.
Maintains a high standard of laboratory practices and reference standards.
Supports change control and quality data integrity.
Educational Requirements
Minimum of bachelor’s degree in chemistry, biochemistry, or chemical engineering.
ASQ auditor training is desirable.
Proficiency in Word, Excel, PowerPoint.
Knowledge of simple statistics: mean, mode, median, standard deviations, regression analysis.
Training in continuous improvement and project management.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Internet News
#J-18808-Ljbffr
Location: Las Vegas, NV
Minimum Requirements
COMPREHENSIVE KNOWLEDGE OF cGMPs AND THE ABILITY TO CORRECTLY INTERPRET MINIMUM STANDARDS.
EXPERIENCE WITH DOCUMENTATION SYSTEMS AND WITH DOCUMENT REVIEW AND AUDITING RESPONSIBILITIES.
WORKING KNOWLEDGE IN QUALITY SCIENCES, STATISTICS, AND COMPUTER-BASED OPERATIONS.
Job Description
MANAGES THE DEVELOPMENT, IMPLEMENTATION AND MAINTENANCE OF QA SYSTEMS AND ACTIVITIES.
MANAGES GENERATION AND REVIEW OF DOCUMENTS USED IN GOOD MANUFACTURING PRACTICES.
MANAGES AUDITS OF PRODUCTION AND QUALITY CONTROL AREAS.
Participates in internal audits, customer audits or regulatory audits.
May audit raw material vendors and prepare assessments.
Conducts site and remote audits based on regulations such as GMP (21CFR 210/211/11) or ISO standards (ISO 9001, 13485:2016).
Ensures manufacturing documentation supports updated filing requirements.
Reviews batch records, cleaning records, environmental monitoring records.
Leads investigations and resolves potential product quality issues.
Investigates nonconformities and establishes root cause analysis (RCA).
Handles deviations and CAPAs, applying corrective and preventative actions.
Manages out-of-specification/out-of-acceptable-tolerance (OOS/OOT) laboratory results.
Addresses supplier complaints (SCAR) and environmental excursions.
Develops schedules and performance standards for QA activities.
Conducts briefings and technical meetings with management and customer representatives.
Writes and reviews SOPs, protocols, and reports for ANDA filings.
Conducts laboratory deviation investigations and maintains laboratory standards.
Leads continuous improvement initiatives, focusing on release time, error rates, and equipment reliability.
Maintains a high standard of laboratory practices and reference standards.
Supports change control and quality data integrity.
Educational Requirements
Minimum of bachelor’s degree in chemistry, biochemistry, or chemical engineering.
ASQ auditor training is desirable.
Proficiency in Word, Excel, PowerPoint.
Knowledge of simple statistics: mean, mode, median, standard deviations, regression analysis.
Training in continuous improvement and project management.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Internet News
#J-18808-Ljbffr