QA Assurance Manager

QA Assurance Manager – Bio Space 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.

• 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.

• 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.

• Mid‑Senior level

• Full‑time

• Quality Assurance

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