An industry-leading Biopharmaceutical organization is seeking a discerning, detail-oriented Quality Complaints Senior Associate to join the Product Complaint & Sample (PC&S) Operations & Transformation division in Thousand Oaks, CA. This crucial, 100% onsite laboratory position is responsible for the rigorous technical evaluation of post-market product complaint returns, directly impacting patient safety and product quality assurance. Operating within a high-throughput, federally regulated environment, the successful candidate will ensure impeccable compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to support the integrity of novel therapeutic modalities.
location: Newbury Park, California
job type: Contract
salary: $28.00 - 32.86 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Technical Evaluation: Execute precise physical, photographic, and radiographic (X-ray) inspections of returned product complaint samples within a Biosafety Cabinet (BSC) environment.
- Documentation & Reporting: Author comprehensive, auditable technical assessment reports and evaluate operational data according to strict regulatory and company guidelines.
- Inventory & Chain of Custody: Manage the secure receipt, documentation, storage, reconciliation, and monthly destruction of complaint return samples, maintaining an flawless chain of custody.
- Cross-Functional Collaboration: Interface effectively with multiple manufacturing sites, business partners, and mail center operations to coordinate the seamless transit of patient-returned materials.
- Laboratory Logistics: Maintain a high-functioning laboratory environment by monitoring consumable inventory, cleaning and preparing specialized Biomailers, and adhering to strict decontamination protocols.
- Data Analysis: Utilize basic statistical and mathematical skills to trend quality data, managing multiple concurrent assignments under tight operational deadlines.
qualifications:
Required:
- Education: Bachelor's degree in the Life Sciences (or an equivalent combination of education and direct industry experience).
- Experience: A minimum of 6 months to 1+ years of experience in a quality assurance, quality control, or manufacturing role within a GMP-regulated pharmaceutical or medical device environment.
- Technical Skills: Proven proficiency with standard word processing, database management, and spreadsheet applications for data entry and trending.
- Operational Agility: Demonstrated ability to work an 8-hour shift with scheduling flexibility, including availability to support operations during standard winter and summer site shutdowns (excluding federal holidays).
- Physical Capabilities: Ability to stand or sit for prolonged periods, transport samples across a corporate campus, and lift storage containers weighing up to 50 lbs.
- Direct, hands-on experience utilizing Good Documentation Practices (GDP) within a regulated laboratory setting.
- Prior experience managing or evaluating product complaints or post-market return samples.
- Strong foundational knowledge of Biosafety Cabinet (BSC) protocols and aseptic material handling.
skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Aseptic Processing, Good Documentation Practices (GDP)
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.
