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Skills: Quality Assurance, cGMP Compliance, Aseptic Technique, Batch Record Review, Gown Qualification
Raleigh, North Carolina, United States · Remote OK
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Raleigh, North Carolina, United States · Remote OK
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
$15/hr–$20/hr
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Raleigh, North Carolina, United States · On-site
$15/hr–$20/hr
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Provide quality oversight for all manufacturing areas to ensure product quality and SOP/GMP compliance. Responsibilities include in-process batch record review, resolving batch issues, and performing aseptic technique coaching.
Requires a Bachelor's degree in science or engineering and at least one year of experience in a cGMP pharmaceutical environment. Candidates must be able to obtain gown certification and meet specific physical requirements for standing and lifting.
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of OUD. Indivior is dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
The Manufacturing Quality Assurance (MQA) Specialist is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist will work closely with production personnel to complete in-process batch record review, resolve batch related issues, and ensure proper good documentation practices.
The responsibilities of this job include, but are not limited to, the following:
In addition to the minimum qualifications, the employee will demonstrate:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
Starting Salary: $64,800-$81,500 USD
*Note actual salary is based on qualifications and experience
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.
Employee Obligations:
Manager Obligations:
EOE/Minorities/Females/Vet/Disabled are encouraged to apply!
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.
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Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Our guiding principles foster a corporate culture of trust, innovation, and a pioneering spirit: • Focus on patient needs to drive decisions • Seek the wisdom of the team • Believe that people’s actions are well intended • Care enough to coach • See it, own it, make it happen • Demonstrate honesty and integrity at all times Community guidelines: https://bit.ly/43QuKrw
Offices: ., Richmond, VA, US · ., Slough, GB · ., Hull, GB · ., Ft. Collins, CO, US
