Seeking a Senior Associate, Quality Assurance (QA) to provide daily compliance oversight on the manufacturing floor, ensuring adherence to GMP standards. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, highly cross-functional environment. This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately. Candidates seeking long-term opportunities with potential for FTE conversion will be prioritized.
Shift: Flexible; Will change based on the manufacturing team supporting (Upstream / Downstream) and rotate every 6 months.
location: Newbury Park, California
job type: Contract
salary: $30.00 - 37.44 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Maintain a purposeful and visible presence on the manufacturing floor to support real-time quality oversight, including inspection support, ASP, and QA assessments.
- Conduct electronic batch record reviews and provide QA approval for SOP revisions.
- Approve work orders and job plans within the Maximo System.
- Provide timely quality support and approval for minor deviations and CAPAs.
- Review and approve Manufacturing Execution System (MES) changes.
- Identify and evaluate compliance issues; provide recommendations and monitor progress of quality records to closure.
- Represent Plant QA in cross-functional team projects to achieve departmental operational goals
- Partner effectively in a team matrix environment with manufacturing operators, engineers, and leadership to ensure best practices in quality culture and GMP compliance.
qualifications:
- Bachelor's Degree (BS) in Biochemistry, Biology, Chemistry, or related science field.
- 1-2+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries.
- Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
- Ability to make Quality based decisions in order to ensure compliance.
- Experience managing projects through to completion & meeting timelines.
- Evaluating documentation and operations according to company procedures.
- Experience working with Quality Systems
- Strong organizational skills and ability to manage multiple tasks at one time
- Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives.
- Manufacturing floor experience in a GMP environment.
skills: SOP, Biology, Chemistry, Good Manufacturing Practices (GMP), Quality Assurance (QA), Good Documentation Practices (GDP), Batch Record
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.
