Serán BioScience
Pharmaceutical Manufacturing
QualityAssuranceAssociateII/III-QualityManagementSystem
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Assurance Associate II/III -Quality Management System at Serán BioScience. Skills: Quality Assurance, GMP, Regulatory Compliance. Support quality systems implementation. Support quality systems continuous improvement”
Industry & Context.
Analytical skills; Problem-solving skills
Must be able to lift up to 15 pounds, Ability to wear required personal protective equipment (PPE), Adheres to consistent and predictable in-person attendance, Applicants must be authorized to work for an employer in the U.S., Unable to sponsor or take over sponsorship of an employment Visa
What They're Looking For.
Must Have
3+ years previous manufacturing, quality control, or quality assurance experience, Bachelor's Degree
Nice to Have
Knowledge of GMP and FDA regulations for clinical trial materials, Working knowledge of Veeva and/or SAP, advanced laboratory and data analysis skills
What You'll Do.
Support quality systems implementation
Support quality systems continuous improvement
Monitor quality systems
Manage quality systems
Author quality records
Review quality records
Approve quality records
Oversee investigation program
Support internal audits
Support client audits
Support regulatory inspections
How You'll Work.
Team & Collaboration
Demonstrated ability to collaborate and work in cross-functional teams
Communication Scope
Excellent verbal and written communication skills
Full Job Description
## Description Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The primary responsibilities of this role will be to support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process. Essential task include reviewing and approving production records, analytical data, and internal QA documentation. Additional responsibilities include conducting risk analyses and investigations and participating in audits and inspections. Quality experience in a GMP Pharmaceutical Manufacturing setting is a requirement for this position with the ability for the title and compensation to commensurate with experience. Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application. ## Duties and Responsibilities Supports the implementation and continuous improvement of the company’s Quality systems Assists in monitoring of Serán quality systems through trending and metrics analysis Supports the management of Serán’s quality systems through program oversight and eQMS administrative functions. Document authorship, review, and approval of SOPs, reports, and quality records Oversight of investigation and CAPA program management Supports internal audits, client audits and regulatory inspections, as needed Other related duties as assi
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