Job description
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
As a member of the Client Facing Quality Assurance team, the Sr. Quality Assurance Specialist will be responsible for the critical, quality review and disposition of raw materials and product batch records. In this role you will effectively communicate with clients, independently manage timelines, and continually strengthen client relations. You will also work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamline processes to maximize productivity. This role will work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. Off-shift, weekend, and overtime duties may be assigned by the manager of the employee.
Minimum Qualifications:
Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
As a member of the Client Facing Quality Assurance team, the Sr. Quality Assurance Specialist will be responsible for the critical, quality review and disposition of raw materials and product batch records. In this role you will effectively communicate with clients, independently manage timelines, and continually strengthen client relations. You will also work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamline processes to maximize productivity. This role will work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. Off-shift, weekend, and overtime duties may be assigned by the manager of the employee.
- Performing product inspections and facility inspections
- Complete line clearances
- General product observation
- Reviewing process validation documentation
- Logging and monitoring quality-related data
- Other Quality Assurance related duties and projects as assigned
Minimum Qualifications:
- Bachelor's Degree in Biology, Chemistry, or other Scientific disciplines
- 3+ years of experience in Biologics, Biotech, Pharmaceuticals, or Medical Devices
- 3+ years of experience working within Quality in a cGMP environment
- 2+ years of experience creating, revising, reviewing, and approving controlled documentation
- 1+ years of experience supporting client audits and regulatory inspections
- 2+ years of Contract Manufactured Organization (CMO) experience
- Batch record review
- Knowledge of governmental regulatory guidelines and regulations relating to the manufacturing of biologics and pharmaceuticals
- Manufacturing or Cleanroom experience
- Experience performing internal audits
Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
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