As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Novato, California
job type: Contract
salary: $42.79 - 50.34 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Ensure quality systems are in place and followed, and execute principal investigation of deviations, LIRs, excursions, adverse trend and child or assessment records as needed.
- Evaluate routine assay validity, calculate and summarize results, analyze data per expectations or specifications. Assist with compilation and verification of trend reports.
- Aid in the preparation of monthly and quarterly reports for in-process and environmental monitoring data, review and analysis of testing trends and Microbial Identifications.
- Manage lab systems (MODA / LIMS) such as builds and upgrades for continued functionality. Efforts include the resolution of MODA / LIMS discrepancies and approval of MODA / LIMS entries.
- Facilitate laboratory equipment maintenance such as PM, calibration and equipment status. Coordinate CMMS processes such as work orders and calibration due dates.
- Identify, vet and own proper CAPA as the result of adverse trends or discrepancies and, if applicable, sequential Effectiveness Check strategy.
- Manage and facilitate lab document revisions to ensure on-time completion. Support implementation of system improvements and procedural revisions, with emphasis on increasing laboratory efficiencies and safety.
- Manage contract lab tests and review of data from these labs.
- Create blanket purchase orders based on the needs of the QC labs.
- Qualify as trainer for a variety of responsibilities. Provide training, troubleshooting and coaching on investigational mindset and critical thinking skills to less experienced staff.
qualifications:
- B.S. degree, or equivalent, in a biological or biochemical science and at least 6 years of experience in a pharmaceutical laboratory, with at least 3 years as part of a QC organization.
- Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
- Writing deviations, laboratory investigations, change controls, and scientific reports preferred.
- Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
- Excellent documentation, written and verbal communication skills are essential.
- Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling initiative, self-direction, objectivity and team advocacy.
- Ability and willingness to provide input to the entire group, with proficiency in both facilitating active and open discussion and laying groundwork for logical decision making.
- Working knowledge of cGMP regulations pertaining to test result disposition, stability protocol generation and execution and critical reagent program management, is desired.
- Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, Project and/or Visio is desired.
- Expertise with laboratory software functions, such as within MODA or LIMS, is optimal.
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
skills: Quality control, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, MS-Project, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
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.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
