Company
QualityAssuranceAssociate
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optimal for Mid candidates.
“Quality Assurance Associate. Skills: Quality assurance, cGMP standards, Risk management, Compliance. Evaluate and review clinical and commercial drug batches to ensure quality.. Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.”
What You'll Achieve.
Ensure the delivery of safe and effective products to patients.; Uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.; Drive forward our mission to improve patient outcomes.
Industry & Context.
Make decisions within limited options to resolve basic problems under supervisor's direction.; problem-solving skills; Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance
What They're Looking For.
Must Have
Bachelor's Degree in Sciences/ Pharmacy with Minimum 4-5 years in Pharma/ Biotech or Master's Degree in Sciences/ Pharmacy with Minimum 2 to 3 years in Pharma/ Biotech, Experience in the pharmaceutical industry and Quality administered systems, Sound knowledge of current Good Manufacturing Practices (part of GxP), Ability to work effectively in a team environment, both within one's own team and interdepartmental teams, Effective written and oral communication skills
Nice to Have
Experience at a manufacturing site., Managing and writing deviations, Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management, problem-solving skills, Ability to work independently and as part of a team, Excellent time management and multitasking abilities, Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance
What You'll Do.
Evaluate and review clinical and commercial drug batches to ensure quality.
Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
Identify and address deviations from manufacturing and packaging standards.
Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
Contribute to project tasks and milestones
organizing work to meet deadlines.
Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
Maintain inspection readiness
support regulatory and customer inspections
and improve quality assurance systems.
Assist manufacturing/packaging staff in real-time compliance error detection and resolution
and lead or participate in Quality Risk Management assessments.
How You'll Work.
Team & Collaboration
Ability to work effectively in a team environment, both within one's own team and interdepartmental teams; Ability to work independently and as part of a team
Communication Scope
Effective written and oral communication skills
Process & Methodology
Contribute to project tasks and milestones, organizing work to meet deadlines.
Full Job Description
**Use Your Power for Purpose** Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes. **What You Will Achieve** In this role, you will: * ## Evaluate and review clinical and commercial drug batches to ensure quality. * ## Ensure product and process documents meet established specifications through rigorous sampling and statistical process control. * ## Identify and address deviations from manufacturing and packaging standards. * ## Approve investigations and oversee change control activities to maintain compliance with configuration management policies. * ## Contribute to project tasks and milestones, organizing work to meet deadlines. * ## Learn and apply basic team effectiveness skills within the immediate work team. * ## Make decisions within limited options to resolve basic problems under supervisor's direction. * ## Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards. * ## Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems. * ## Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments. **Here Is What You Need (Minimum Requirements)** * ## Bachelor's Degree in Sciences/ Pharmacy with Minimum 4-5 years in Pharma/ Biotech or Master's Degree in Sciences/ Pharmacy with Minimum 2 to
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