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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. 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. With Ferring, 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. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country. Responsibilities: The responsibilities of the Quality Operations Specialist I include but not limited to: Perform thorough documentation review using internal procedure and controls. Review intermediate and bulk manufacturing batch records. Perform real-time batch record review for final packaged, labeled product (at time of shipment) Review test records for drug substance, donor, and raw materials including drug substance. Perform label review and approval, including expiration date verification, for intermediate, bulk and finished product. Determine disposition of material and product Create/review Certificate of Analysis Create Certificate of Compliance, as applicable Disposition components, excipients, intermediates, drug substance and drug product. Support daily operations. Issue MBRs and logbooks. Monitor production activities and identify deviations from procedures. Perform investigations and partner with manufacturing to complete operational investigations. Own Change Controls and document updates Execute material Holds & Rejects Support other Quality Operations & Quality Systems functions as required. Requirements: Education and Experience: 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 Preferred 1yr or more experience in a Quality role with general understanding of manufacturing processes Working knowledge of cGMPs Preferred working knowledge of quality regulations including 21 CFR 210, 211, 600 & 610 Good oral, written, and interpersonal skills, ability to function effectively in a team and manage time efficiently, customer focused approach to activities and interactions. Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities. 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. 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 eq itable, 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. Our Compensation and Benefits At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $55,000 to $70,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance. Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, 40 hours of sick time, vacation time for full time employees to accrue up to 150 hours in the first four (4) years of employment, and 187.50 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here. Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws. 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. Location:Roseville, Minnesota We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled