Quality Assurance Associate II/III -Quality Management System

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 assigned

Required Skills and Abilities

• Knowledge of GMP and FDA regulations for clinical trial materials preferred
• Excellent verbal and written communication skills
• Excellent time management skills with a proven ability to meet deadlines
• Excellent organizational skills and attention to detail
• Demonstrated ability to collaborate and work in cross-functional teams
• Scientific curiosity and willingness to learn
• Demonstrated experience in characterization and analytical techniques relevant to the pharmaceutical industry
• Demonstrated experience with advanced laboratory and data analysis skills preferred
• Strong analytical and problem-solving skills

Education and Experience

• Minimum of a Bachelor's Degree, preferably in a scientific discipline
• 3+ years previous manufacturing, quality control, or quality assurance experience
• Working knowledge of Veeva and/or SAP preferred

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds at times
• Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoes
• Adheres to consistent and predictable in-person attendance