Quality Assurance Associate II/III -Quality Management System

Seranbio; Bend (OR); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Life and long-term disability

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience is seeking an experienced Quality Assurance Associate to support GMP quality systems in our Bend, Oregon facility. You will perform day-to-day QA tasks, assist in document management, training, quality events, and participate in audits and inspections.

The role emphasizes collaboration across cross-functional teams, data analysis, CAPA management, and eQMS administration. A Bachelor’s in a scientific field and 3+ years in manufacturing, quality control, or QA are preferred, with

Qualifications

• Bachelor’s degree in a scientific field required.
• 3+ years in manufacturing, quality control, or QA.
• Knowledge of GMP and FDA regulations preferred.
• Experience with document management and CAPA.
• Proficient in audits and inspections support.

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

Skills

GMP knowledge

FDA regulations familiarity

Communication skills

Time management

Detail-oriented

Cross-functional collaboration

Analytical skills

Scientific curiosity

Laboratory data analysis

Education

Bachelor’s Degree in scientific discipline

Tools

Veeva

SAP

Job description

Serán BioScience is searching for an experienced Quality Assurance Associate to support quality systems programs. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department in a GMP facility manufacturing pharmaceutical products. Tasks include supporting quality system programs such as document management, training, and quality event programs. Additional responsibilities include assisting in the maintenance of the electronic Quality Management System, conducting risk analyses and investigations, and participating in audits and inspections. Preference will be given to candidates within the pharmaceutical industry, while those with Quality oversight experience encouraged to apply.

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

Qualifications

• 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
• 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
• 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

Additional Information

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.

Company Information

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

Benefits Summary

Serán 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. Serán 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.

Location

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