PRIMARY OBJECTIVE OF POSITION:
- Under minimal supervision, the Quality Specialist, Stability supports the stability program under regulatory requirements and ISO 13485 and runs stability studies from initial batch/lot selection to final report generation and study destruction; works closely with Quality, R&D, and Operations to assure appropriate batch/lot selection, initiation, and execution of Stability studies in a compliant and timely manner.
location: Rocklin, California
job type: Contract
salary: $25 - 30 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
JOB RESPONSIBILITIES:
- Support activities to ensure proper maintenance of the Rocklin stability program
- Analyze and interpret laboratory/stability data
- Draft, review, and update stability protocols upon revisions to specifications, or regulatory requirements
- Generate/review stability study summary reports and verify associated source data
- Own investigations pertaining to OOS and OOT stability results and/or deviations
- Perform impact assessment of temperature/humidity excursions
- Escalate to Quality management any out-of-trend or out-of-specification data immediately upon discovery
- Accurately document all activities with adherence to cGMP and company standards
- Maintain work area and documentation in a neat and organized manner
- Work with computers as well as laboratory software, or proprietary software as needed
- Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to management
- Write, revise, and/or review Standard Operating Procedures (SOPs)
- Adhere to SOPs and GMP regulations and policies
- Support internal and external audits as required
- Maintain current training requirements
- Meet productivity standards without sacrificing quality and safety
- Adhere to established safety procedures; use equipment and materials properly
- Understand, support, and communicate Company mission, vision, and values
- Work on weekends or extended hours as needed
- Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
- Other duties as assigned or required to support the business
qualifications:
REQUIRED:
- BS in Chemistry/Biochemistry, Biology or related field.
- Minimum 3 years of experience working in a regulated environment which includes stability.
- Experience working in ISO 13485 and/or FDA regulated environment.
- MS in Chemistry/Biochemistry, Biology or related field.
- Experience in IHC preferred.
- Experience with SAP and/or SAP NEXT strongly preferred.
skills: SOP, Quality Assurance, Biology, Chemistry, ICH Regulations, GMP (Good Manufacturing Practice)
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 health, an incentive and recognition program, and 401K contribution (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 in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
