Quality Assurance Operations Specialist III
- Employer
- Sage Therapeutics
- Location
- Working from Home
- Start date
- Jun 18, 2022
View more
- Discipline
- Clinical, Clinical Medicine, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, integrative thinker for a role as a Specialist III, QA Operations. The successful candidate will work as part of the Quality team to provide QA oversight and support of commercial and clinical development projects within the CMC teams. In this position, you will be an integral contributor to the Technical Operations team, interfacing with both internal and external stakeholders.
Roles and Responsibilities
Perform the activities associated with manufacturing of clinical and commercial materials including batch record review, change management, deviations, and investigations.
Support lot disposition activities to ensure that materials are released in accordance with regulatory requirements, cGMPs, and policies and procedures and within project lead times.
Interface with internal departments, primarily Quality, Regulatory Affairs, and CMC, as well as external vendors.
Review and approve documents necessary to support the programs.
Contribute to the evaluation and mitigation of program risks and escalation of potential quality issues.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Basic Qualifications
Bachelor’s degree.
2+ years of experience in Quality Assurance.
Preferred Qualifications
4+ years of Quality Assurance experience in the pharmaceutical or drug development industry.
Sound knowledge of cGMPs.
Experience in development, manufacturing, analytical, or validation is a plus.
Excellent interpersonal and problem-solving skills.
Ability to coordinate timelines with internal customers and external clients and vendors.
Experience building internal and external relationships and working with external vendors
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Strong written and verbal communication skills.
Excitement about the vision and mission of Sage
Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.
Employment Type:EmployeeNumber of Openings:1Job ID:R001340#Biotechnology #Careers #ThisIsSageAll Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
EEO is the Law - Poster Supplement
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.
Company
Welcome To The Workplace With A Difference
Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.
At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.
Stock Symbol:
SAGE
- Website
- https://www.sagerx.com/
- Phone
- 617-299-8380
- Location
-
215 First Street
Cambridge
MA
02142
United States
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