We are seeking a Manufacturing Investigations & Continuous Improvement Specialist to join our onsite manufacturing organization in a fast-paced contract manufacturing (CMO/CDMO) environment.
This role is responsible for leading high-quality cGMP investigations, driving root cause elimination, and implementing sustainable corrective and preventative actions (CAPAs). The Specialist will play a critical role in advancing continuous improvement initiatives, enhancing process robustness, and improving process reliability.
The ideal candidate combines strong technical writing, analytical problem-solving, and cross-functional collaboration to ensure regulatory compliance, reduce recurring quality events, and support inspection readiness.
This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.
The pay range for this position is between $105,000 - $115,000 annually. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.?
location: Carlsbad, California
job type: Permanent
salary: $105,000 - 115,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
Investigations & Continuous Improvement
- Lead end-to-end cGMP investigations (deviations, non-conformances, complaints) with a focus on root cause identification, risk mitigation, and prevention of recurrence
- Apply structured root cause methodologies (e.g., 5 Whys, Fishbone, FMEA) to identify systemic issues and drive continuous improvement
- Develop, implement, and track CAPAs, ensuring effectiveness, sustainability, and measurable outcomes
- Analyze and trend data to identify recurring issues and improvement opportunities
- Evaluate and collaborate on cGMP-compliant documentation, including SOPs, production records, studies, validation protocols, and reports
- Initiate and manage change controls in support of process, equipment, and continuous improvement initiatives
- Ensure documentation meets cGMP and FDA regulatory expectations, with a focus on clarity, accuracy, and compliance
- Partner with Manufacturing, Engineering, MSAT, Facilities, Finance and Quality to implement process improvements
- Contribute to inspection readiness by maintaining high-quality investigation and documentation standards
- Lead interdepartmental continuous improvement initiatives
qualifications:
- Bachelor's degree in biology, Chemistry, Engineering, or related scientific discipline
- 5+ years of experience in investigations in a cGMP manufacturing, quality, or continuous improvement role (CMO/CDMO experience preferred)
- Demonstrated experience leading GMP investigations and authoring deviations, non-conformances, complaints, CAPAs, and change controls
- Strong technical writing skills with the ability to translate complex technical information into clear, compliant documentation
- Hands-on experience with root cause analysis tools (5 Whys, Fishbone, FMEA) and data trending/metrics analysis
- Working knowledge of cGMP regulations, FDA expectations, and Quality Systems
- Proven ability to collaborate effectively in a cross-functional, onsite manufacturing environment
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Experience with eQMS/document management systems (MasterControl preferred)
- Experience in a contract manufacturing (CDMO/CMO) environment supporting multiple clients
- #LI-CV1
skills: Quality Assurance (QA), Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
