Massachusetts Green Jobs

usa-quality assurance associate ii (scientific) - first shift.

• waltham , massachusetts

• posted today

job details

summary

• $45 - $47.64 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference49465

job details

job summary:

As the 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. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, now!

location: Waltham, Massachusetts

job type: Contract

salary: $45.00 - 47.64 per hour

work hours: 8 to 4

education: Bachelors

responsibilities:

• Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.

• Perform QA review of Executed Batch Records.

• Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.

• Perform QA review and approval on SOPs, forms, WI, and other document types.

• Provide SAP support for GMID and BOM approval.

• Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.

• Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.

• Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.

• Participate in Quality Risk Assessments

• Assist with internal and external audits.

• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.

• Assume additional responsibilities as assigned.

qualifications:

• Bachelor's and/or 8+ years of relevant experience

• Minimum 5 years of experience in Quality

• Working knowledge and ability to Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.

• Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.

• Must have excellent attention to detail, project and time management skills, and the ability to

manage multiple priorities with aggressive timelines.

• Preferred experience with outsourced manufacturing and testing operations

• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

skills: Quality control, SOP, Quality Assurance, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint

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.