Quality Assurance Associate
Must-havesKnowledge of CAPA and Deviations10 years of experience in Quality AssuranceExperience in pharma or biomed environmentUnderstanding of production/manufacturing processesBachelor's DegreePlussesExperience in technical writingSAP experience
Job Description:
As a privately-owned, biopharmaceutical company, we deliver life-changing therapies that help people build families and live better lives.
Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy.
Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy:
disease.
As the Associate, Quality Assurance you will be responsible for creating and maintaining current specifications, addressing change controls for specification updates, working with quality metrics, SOPs, deviations, CAPA to assist with ensuring the site is in compliance with SOPs and regulatory requirements.
Will be a back-up for other responsibilities to ensure proper staffing to meet departmental timelines.
You will be joining a recognized leader, identified as one of The World's Most Innovative Companies by Fast Company, and honored by Fortune with inclusion on its Change the World List, for addressing society's unmet needs.
Our Company is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
Creation and revision of specifications for current materials/products and new materials/products supporting tech transfer activities and artwork revisions.
Create, manage, and/or implement change controls for various activities.
Creation or review of quality metrics for monthly Quality Review Board meetings.
Ensure metrics are met for items personally responsible for.
Knowledge of deviation and CAPA system - able to perform investigation and root cause analysis.
Participate in internal audits and regulatory inspections as required.
Creation and revision of SOPs utilizing an electronic system.
Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site.
Knowledge of LIMS and Oracle systems.
Batch Record Review for media fills, compounding/filling/capping, visual inspection, labeling and packaging activities.
Requirements:
Bachelor degree in Life Sciences Minimum 5 years of Quality Assurance experience in the pharmaceutical industry Knowledge of sterile operations preferred.
Knowledge of cGMPs and GLPs Demonstrated effective communication and interpersonal skills across multiple departments.
Strong organizational skills Recommended Skills Auditing Communication Coordinating Interpersonal Skills Labeling Manufacturing Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
Job Description:
As a privately-owned, biopharmaceutical company, we deliver life-changing therapies that help people build families and live better lives.
Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy.
Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy:
disease.
As the Associate, Quality Assurance you will be responsible for creating and maintaining current specifications, addressing change controls for specification updates, working with quality metrics, SOPs, deviations, CAPA to assist with ensuring the site is in compliance with SOPs and regulatory requirements.
Will be a back-up for other responsibilities to ensure proper staffing to meet departmental timelines.
You will be joining a recognized leader, identified as one of The World's Most Innovative Companies by Fast Company, and honored by Fortune with inclusion on its Change the World List, for addressing society's unmet needs.
Our Company is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
Creation and revision of specifications for current materials/products and new materials/products supporting tech transfer activities and artwork revisions.
Create, manage, and/or implement change controls for various activities.
Creation or review of quality metrics for monthly Quality Review Board meetings.
Ensure metrics are met for items personally responsible for.
Knowledge of deviation and CAPA system - able to perform investigation and root cause analysis.
Participate in internal audits and regulatory inspections as required.
Creation and revision of SOPs utilizing an electronic system.
Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site.
Knowledge of LIMS and Oracle systems.
Batch Record Review for media fills, compounding/filling/capping, visual inspection, labeling and packaging activities.
Requirements:
Bachelor degree in Life Sciences Minimum 5 years of Quality Assurance experience in the pharmaceutical industry Knowledge of sterile operations preferred.
Knowledge of cGMPs and GLPs Demonstrated effective communication and interpersonal skills across multiple departments.
Strong organizational skills Recommended Skills Auditing Communication Coordinating Interpersonal Skills Labeling Manufacturing Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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