Job Description
Job Description
Quality Assurance Specialist II - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Quality Assurance Specialist II in San Diego, CA who possess:
- BS - Chemistry, Biology, Pharmaceutical Sciences
- Quality Assurance Experience - 3+ yrs.
- GMP level Audits/CDMO a +/pharma or biotech
FULL DESCRIPTION: The Quality Assurance Specialist II supports quality and compliance activities within a regulated manufacturing environment. This role helps ensure products and processes meet established quality standards, regulatory requirements, and internal procedures. The successful candidate will have experience working in cGMP operations, strong attention to detail, and the ability to collaborate effectively across departments.
The selected candidate will be responsible for:
- Review manufacturing and laboratory documentation to ensure accuracy, completeness, and compliance with quality standards.
- Support material and product disposition activities in accordance with established procedures.
- Assist with investigations related to deviations, quality events, corrective actions, and process changes.
- Participate in audit preparation efforts and support regulatory inspection activities.
- Ensure documentation practices comply with company procedures and regulatory expectations.
- Work closely with Production, Quality Control, and other departments to address quality concerns and support operational improvements.
- Maintain quality records and documentation within paper-based and electronic systems.
- Assist with the creation, revision, and maintenance of standard operating procedures and related quality documents.
- Provide quality oversight during manufacturing operations as needed.
- Contribute to continuous improvement initiatives and other quality-related projects.
The selected candidate will also possess:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or another related scientific field; equivalent industry experience may be considered.
- Approximately 3–5 years of experience in Quality Assurance within pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments.
- Experience working within cGMP quality systems is preferred.
- Understanding of applicable regulatory requirements, including FDA and international quality standards.
- Experience supporting investigations, CAPAs, document control, and quality system processes.
- Familiarity with electronic quality management systems (eQMS) and Microsoft Office applications.
- Strong organizational, analytical, and communication skills.
- Ability to manage multiple priorities and work effectively in a team-oriented environment.
Salary Range: $29 to $39/hour
More information can be found at www.simplybiotech.com.
Company DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.
Company Description
Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.