Quality Assurance Associate II / III

Quality Assurance Associate II / III

Sern 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 Serns 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.

Sern 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

• Documents authorships, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
• Applies working knowledge of best practices in GMP and understands how Quality integrates with other business areas
• Initiates and oversees investigations
• Manages corrective and preventive actions (CAPA)
• Supports internal audits, client audits and regulatory inspections, with the potential to host
• Manages controlled document issuance and archival
• Performs quality reviews with minimal oversight
• Communicates quality-related information to internal teams with minimal guidance
• Responsibilities may increase in scope to align with company initiatives
• Performs all other related duties as assigned

Required Skills and Abilities

Education and Experience

Physical Requirements

Visit https : / / www.seranbio.com / careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary : Sern employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Sern covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees wellbeing, along with access to pet insurance.

The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701

PI9c43ff18f7a1-30511-39126449