With limited supervision, QC Associate II, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.
location: Vacaville, California
job type: Contract
salary: $24.07 - 28.32 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Perform a broad variety of basic and moderately complex tests with documentation according to GMP
- Review data and assess against established acceptance criteria
- Perform technical review of peer-generated data
- Evaluate data to identify trends and/or establish limits
- Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
- Identify and troubleshoot technical problems
- Identify gaps in systems and procedures
- Receive and provide training
- Participate in assay transfer and assay validation
- Perform equipment qualification / maintenance
- Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
- Support the maintenance and compliance of operational areas
- Assure and apply GMP throughout operations
- Coordinate with customers to support multi-site operational activities
- Support internal and external audits and regulatory inspections
- Works to meet schedules, timelines, deadlines
- Participate in and/or lead group and project teamwork; project and process improvements
- Write protocols and reports under limited supervision
- Meets scheduled performance of 95% on time
- Perform other duties as requested by managers to support Quality activities
qualifications:
- B.S. /B.A. degree and three years experience or Master's Degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.
- Strong verbal and written communication skills, ability to organize and present information both formally and informally.
- Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
- Routinely exercises sound judgment, reasoning and problem solving.
- Capable of working under limited supervision and determining own short term priorities.
skills: Quality control, GMP (Good Manufacturing Practice), Corrective and Preventive Actions (CAPA)
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.
