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location: Novato, California
job type: Contract
salary: $23.96 - 27.21 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
?Job Purpose:
The Quality Control Process Monitoring (QCPM) Analyst is responsible for performing environmental monitoring and microbiological/analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Water testing, Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation
CHARACTERISTICS
Functional activities may include: performing a wide variety of microbiological and/or analytical assays, perform environmental monitoring sampling and testing of facilities, equipment, and utilities, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorm further development or improvement ideas for procedures. Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritize routine work effectively.
RESPONSIBILITIES
- 1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
- 2. Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
- 3. Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.
- 4. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
- 5. Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
- 6. Assist with monitoring and the control of laboratory supply and critical reagent inventories.
- 7. Perform growth promotion of media and microbial identification testing.
- 8. Qualify as trainer for specified methods, provide training to less experienced staff.
- 9. Provide on call coverage to support oversight of QC laboratory equipment functionality.
- 10. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
- 11. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- 12. Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
- 13. Perform other responsibilities as deemed necessary.
qualifications:
QUALIFICATIONS
- 1. Bachelor of Science degree.
- 2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.
- 3. Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
- 4. Demonstrated working knowledge with respect to certified functional activities.
- 5. Good documentation, written and verbal communication skills are essential.
- 6. Must possess the ability to perform most tasks with minimal supervision.
- 7. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
- 8. 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, SOP, 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.
