Quality Assurance Associate II/III

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

Participates in internal and third-party audits.

Supports client audits and regulatory inspections

Supports company’s supplier quality program

Assists in the oversight and implementation of continuous improvement of the company’s Quality systems 

Supports the risk management program and conducts risk assessments

Document authorship, review, and approval of SOPs, reports, and quality records.

Other related duties as assigned 

Required Skills and Abilities

Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211)

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

Strong analytical and problem-solving skills

Ability to prioritize tasks and to delegate them when appropriate

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 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