We are looking for a detail-oriented, team-driven, and quality-focused professional to join the Quality Assurance team as a Senior Associate with a leading biopharmaceutical company headquartered in Thousand Oaks, CA. In this role, you will be an essential part of operations, providing oversight and support to ensure compliance and quality standards on the manufacturing floor. If you have a strong background in quality assurance and GMP manufacturing operations, apply today!
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
location: Newbury Park, California
job type: Contract
salary: $30.00 - 37.44 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Real-time QA oversight during operations and review of batch records, MES, etc., on-the-floor QA in Drug Product Manufacturing, Hands-on with manufacturing teams and processes, MES, Maximo, electronic batch records - all shifts?
- Purposeful presence on the manufacturing floor, including inspection support, ASP and QA assessments,
- Electronic batch record review
- SOP revision approval
- Maximo System - Work order, job plan approvals
- Quality support and approval of minor deviations and CAPA records
- MES revisions and approvals
qualifications:
Required:
- BS in Biochemistry, Biology, Chemistry, or related science.
- Manufacturing floor experience in a GMP environment.
- Ability to perform GMP operations (SOPs, training, documentation).
- Experience managing projects to completion.
- Ability to evaluate documentation/operations per procedures.
- Experience working with Quality Systems.
- Strong organizational and multitasking skills.
- Effective written and verbal communication.
- Team player and independent worker.
- Displays leadership attributes and drives improvement.
- Solid understanding of aseptic principles.
skills: Quality Assurance, CAPA, GMP (Good Manufacturing Practice), Manufacturing Operations
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.
