Quality Assurance Associate II/III

Serán BioScience; Emeryville (CA); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Paid time off

Employer contributions to retirement account

Various health plans

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience is looking for an experienced Quality Assurance Associate to ensure regulatory compliance in manufacturing oral solid dosage drugs. The role involves auditing, supplier quality management, and overseeing continuous improvement in Quality Management Systems.

Applicants should have a Bachelor's Degree in a scientific field and 3+ years of relevant experience. Strong knowledge of GMP and FDA regulations is essential. Benefits include over four weeks of paid time off and comprehensive health plans.

Qualifications

• Minimum of 3+ years previous manufacturing, quality control, or quality assurance experience.
• Proven ability to meet deadlines and prioritize tasks.

Responsibilities

• Participates in internal and third-party audits.
• Supports client audits and regulatory inspections.
• Assists in the oversight and implementation of continuous improvement.
• Conducts risk assessments and supports risk management programs.

Skills

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

Excellent verbal and written communication skills

Time management skills

Organizational skills and attention to detail

Collaboration in cross-functional teams

Strong analytical and problem-solving skills

Education

Bachelor's Degree in a scientific discipline

Tools

Veeva

Job 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. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing and testing pharmaceutical products. Tasks include auditing and audit support, supplier quality management, and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA. Preference will be given to candidates with Quality Assurance experience in the pharmaceutical industry, while those with Quality oversight experience are encouraged to apply.

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

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

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.