BioSpace
QA Assurance Manager – BioSpace
Minimum Requirements – 10 Years Experience
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.
All SOPs, work instructions, forms and protocols for validations.
Manages audits of production and quality control areas.
Participates in scheduled internal audits, customer audits or regulatory audits.
May audit raw‑material vendors and prepare audit findings.
Supplier audits based on self‑assessment questionnaires.
Site/remote audits based on regulations such as GMP (21 CFR 210/211/11), ISO 9001, ISO 13485:2016, ISO 14644, or EU annex 1.
Manufacturing documentation for updated filing: batch records, cleaning records, environmental monitoring records.
May lead investigations and resolve potential product quality issues.
Events (investigation, closure or escalation into deviation & RCA determination).
Deviations – investigated, RCA determined, corrective and preventative actions implemented or escalated into CAPA if high frequency or high impact.
CAPAs created from audit findings, high‑risk events, repeated deviations or supplier complaints.
OOS/OOT from laboratory testing.
SCAR – complaints to suppliers of materials, components, contract services or equipment.
Environmental excursions – failure of environment to meet ISO 14644 or EU annex 1 requirements.
Develops schedules and performance standards, including manufacturing schedules, QC testing schedules, raw‑material, in‑process, finished‑product, stability study, internal audit, pest‑control inspection, and customer audit schedules.
Performance standards – KPIs for quality systems, QC release times, finished‑product testing, production/QA performance standards such as time to release product to the market.
Conducts briefings and technical meetings for management and customer representatives.
Writes and reviews SOPs, protocols and reports for ANDA filings.
Conducts investigations on laboratory deviations.
Maintains laboratory standards (reference standards to USP, EU Pharmacopoeia, house standards or CRM standards).
Leads continuous improvement initiatives, including:
Improve release time for batch records and finished product to clients or market.
Decrease error rates in the laboratory.
Minimize analyst errors through focused training.
Minimize equipment failures via programmatic maintenance and calibration.
Decrease time to lease raw materials through effective scheduling after 5S program.
Improve KPI for deviation closure by regularly meeting with various departments and deviation owners.
Educational Requirements
Minimum of bachelor’s degree in chemistry, biochemistry or chemical engineering.
ASQ auditor training desirable.
Ability to carry out simple operations – Word, Excel, PowerPoint.
Simple statistics – mean, mode, median, standard deviations, regression analysis required.
Other requirements include training in continuous improvement and project management.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
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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.
All SOPs, work instructions, forms and protocols for validations.
Manages audits of production and quality control areas.
Participates in scheduled internal audits, customer audits or regulatory audits.
May audit raw‑material vendors and prepare audit findings.
Supplier audits based on self‑assessment questionnaires.
Site/remote audits based on regulations such as GMP (21 CFR 210/211/11), ISO 9001, ISO 13485:2016, ISO 14644, or EU annex 1.
Manufacturing documentation for updated filing: batch records, cleaning records, environmental monitoring records.
May lead investigations and resolve potential product quality issues.
Events (investigation, closure or escalation into deviation & RCA determination).
Deviations – investigated, RCA determined, corrective and preventative actions implemented or escalated into CAPA if high frequency or high impact.
CAPAs created from audit findings, high‑risk events, repeated deviations or supplier complaints.
OOS/OOT from laboratory testing.
SCAR – complaints to suppliers of materials, components, contract services or equipment.
Environmental excursions – failure of environment to meet ISO 14644 or EU annex 1 requirements.
Develops schedules and performance standards, including manufacturing schedules, QC testing schedules, raw‑material, in‑process, finished‑product, stability study, internal audit, pest‑control inspection, and customer audit schedules.
Performance standards – KPIs for quality systems, QC release times, finished‑product testing, production/QA performance standards such as time to release product to the market.
Conducts briefings and technical meetings for management and customer representatives.
Writes and reviews SOPs, protocols and reports for ANDA filings.
Conducts investigations on laboratory deviations.
Maintains laboratory standards (reference standards to USP, EU Pharmacopoeia, house standards or CRM standards).
Leads continuous improvement initiatives, including:
Improve release time for batch records and finished product to clients or market.
Decrease error rates in the laboratory.
Minimize analyst errors through focused training.
Minimize equipment failures via programmatic maintenance and calibration.
Decrease time to lease raw materials through effective scheduling after 5S program.
Improve KPI for deviation closure by regularly meeting with various departments and deviation owners.
Educational Requirements
Minimum of bachelor’s degree in chemistry, biochemistry or chemical engineering.
ASQ auditor training desirable.
Ability to carry out simple operations – Word, Excel, PowerPoint.
Simple statistics – mean, mode, median, standard deviations, regression analysis required.
Other requirements include 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