Quality Operations Specialist (Weekend)
Full Time
Roseville, MN
Posted
Job description
Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers 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.
Ferring US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
Summary:
The Quality Operations Specialist I is responsible for performing thorough documentation review using internal procedures and controls, identifying any exceptions from approved procedures, determining disposition of material and product, executing material holds & rejects, supporting daily operations, and performing incoming inspections for excipients and components.
**Hours for this position will be Friday – Monday 6:00am-2:00pm**
Responsibilities:
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Perform thorough documentation review using internal procedure and controls.
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Review intermediate and bulk manufacturing batch records.
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Perform real-time batch record review for final packaged, labeled product (at time of shipment).
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Review test records for drug substance, donor, and raw materials including drug substance.
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Perform label review and approval, including expiration date verification, for intermediate, bulk and finished product.
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Determine disposition of material and product.
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Create/review Certificate of Analysis
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Create Certificate of Compliance, as applicable.
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Create CTA Fax Back file for notification to Health Canada (BGTD).
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Disposition components, excipients, intermediates, drug substance and drug product
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Support daily operations.
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Issue MBRs and logbooks
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Monitor production activities and identify deviations from procedures,
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Perform investigations and partner with manufacturing to complete operational investigations.
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Own Change Controls and document updates
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Execute material Holds & Rejects
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Support other Quality Operations & Quality Systems functions as required.
Requirements:
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Bachelor’s degree in a scientific field with 2 or more years in the pharmaceutical and/or biopharmaceutical industry (or related regulated industry). Note: An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience requirements
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Preferred 1yr or more experience in a Quality role with general understanding of manufacturing processes.
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Working knowledge of cGMPs.
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Preferred working knowledge of quality regulations including 21 CFR 210, 211, 600 & 610.
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Good oral, written, and interpersonal skills, ability to function effectively in a team and manage time efficiently, customer focused approach to activities and interactions.
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Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.
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Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs, recognize variances from cGMPs, completes routine tasks with little or no oversight and requires moderate direction to complete more complex tasks.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance.
Location:
Roseville, Minnesota
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