Quality Systems Specialist - Sterile Drug Product Manufacturing
Johnson Service Group
- Carlsbad, CA
- 4 days ago
Highlights
We are seeking an experienced Quality Systems Specialist to lead investigations, root-cause analyses, and CAPAs within a sterile drug product manufacturing environment. Qualifications Bachelor’s degree in biology, chemistry, engineering, life sciences, or a related field strongly preferred.
Numbers & Facts
| Location | Carlsbad, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 1,000 to 1,499 employees |
| Year Founded | 1984 |
| Website | https://www.jsginc.com/ |
Description
Johnson Service Group, is looking to hire a Quality Systems Specialist for a biotech manufacturing company in Carlsbad, CA.
Direct Hire | Onsite | Pay range for this position is $36 - $40 per hour
Position Overview
We are seeking an experienced Quality Systems Specialist to lead investigations, root-cause analyses, and CAPAs within a sterile drug product manufacturing environment. This role will ensure compliance with FDA, cGMP, ISO, and ICH requirements while maintaining inspection readiness.
Key Responsibilities
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
Direct Hire | Onsite | Pay range for this position is $36 - $40 per hour
Position Overview
We are seeking an experienced Quality Systems Specialist to lead investigations, root-cause analyses, and CAPAs within a sterile drug product manufacturing environment. This role will ensure compliance with FDA, cGMP, ISO, and ICH requirements while maintaining inspection readiness.
Key Responsibilities
- Lead thorough investigations into batch deviations, nonconformances, out-of-specification results, and product failures
- Investigate customer complaints by reviewing production records, historical quality data, and interviewing appropriate personnel
- Perform root-cause and risk analyses and develop appropriate CAPAs
- Ensure investigations and manufacturing documentation comply with FDA, cGMP, ISO, ICH, and other applicable requirements
- Conduct historical quality-system searches to identify similar events, recurring issues, and potential trends
- Prepare and present quality metrics, investigation findings, and reports to support management decision-making
- Partner with Manufacturing and other departments to ensure investigations are accurate, complete, and resolved on time
- Monitor CAPA effectiveness and drive assigned actions through completion
- Lead quality-related training sessions as needed
- Identify and support process improvements related to investigations and quality systems
- Lead the internal audit program
- Assist with hosting client, supplier, and regulatory audits and coordinate responses to audit findings
- Support visual inspection activities for finished products
- Perform other related duties as assigned
- Bachelor’s degree in biology, chemistry, engineering, life sciences, or a related field strongly preferred
- Minimum of four years of experience in pharmaceutical or biotechnology manufacturing
- Significant experience working in a GMP-regulated environment and conducting quality investigations
- Strong knowledge of FDA regulations, cGMP requirements, and ICH guidelines
- Demonstrated experience with root-cause analysis, risk assessment, deviations, CAPAs, and nonconformances
- Excellent technical writing, analytical, and problem-solving skills
- Strong attention to detail with the ability to manage multiple priorities in a deadline-driven environment
- Ability to make sound decisions regarding product and material quality
- Excellent communication skills and the ability to collaborate across departments
- Strong initiative, accountability, and willingness to take ownership of projects through completion
- Experience with MasterControl and NetSuite is a plus
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
About Company
At JSG, We Understand People
It is our mission to empower people, help our clients reach their goals, and hire motivated individuals.
Since our start in 1984, we’ve worked hard to establish our present position as the most effective cross-industry staffing and consulting solution available.
Headquartered in Chicago, IL with local offices throughout the United States and Canada, JSG proudly serves a diverse range of industries with the right solutions to help clients reach their company goals. Our client-centric approach enables us to create personalized solutions for businesses in need of top-tier talent. Our dedication doesn’t stop at our clients. We strive to connect candidates with opportunities that match their skills and goals. More than just a go-between, we are a dependable bridge, uniting top talent with suitable opportunities, facilitating shared opportunities and growth.