Sr Quality Ops Analyst

job summary:
Join a top-tier global pharma leader in San Diego as a Sr Quality Ops Analyst. This high-impact role supports a critical Leave of Absence (LOA) with a strong possibility for extension or transition into a long-term position. Operating in a fast-paced environment, you will bridge QA Development and Operations, ensuring document control excellence and process improvement for Clinical and IVD manufacturing.

location: San Diego, California
job type: Contract
salary: $50.00 - 54.25 per hour
work hours: 9 to 5
education: High School

responsibilities:

• Manage the end-to-end document lifecycle, including processing, tracking, and auditing Change Requests (CR) and Change Orders (CO) in Ensur.
• Write, review, and maintain high-quality controlled documentation (WIs, policies, and procedures) for Laboratory Services.
• Facilitate the Product Development Process (PDP) transition to operations, including documenting Design Inputs/Outputs.
• Oversee the quality training program, maintaining organizational training matrices and ensuring regulatory compliance.
• Support supplier management, risk management (FMEA), and validation protocols to identify and mitigate quality risks.
• Collaborate cross-functionally to implement process improvements and track QMS metrics using tools like SAP and Excel.

qualifications:
Required:

• B.S. in Molecular Biology or a related scientific field.
• Minimum of 5 years in a QA role within a regulated environment (IVD manufacturing preferred).
• Strong knowledge of 21 CFR Part 820, ISO 13485, and CLIA/CAP standards.
• Proven experience with complex QMS platforms (e.g., Ensur, EtQ, or SAP).
• Advanced proficiency in Microsoft Excel and Word for data trending and process mapping.

Preferred:

• Quality certifications such as CQE or CQA.
• Experience with LucidChart for developing process maps.

skills: In Vitro, Change Control Management, Quality Assurance (QA), Good Documentation Practices (GDP), 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 [email protected].


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.