USA-Quality Assurance Associate III (Scientific)- First Shift at Randstad USA

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, apply now!

 
location: Waltham, Massachusetts
job type: Contract
salary: $60 - 62 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

- Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials

- Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.

- Ensure that all requirements, as stipulated in the appropriate QTA, have been met.

- Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur.

- Write and revise SOP, forms, WI, and any other document types

- Assist with internal and external audits.

- Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.

- Assume additional responsibilities as assigned.

- Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.

- Write and revise SOP, forms, WI, and any other document types

- Assist with internal and external audits.

- Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.

 
qualifications:

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

- Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences)

- Working knowledge and ability to apply 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.

Must Have Experience:

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

- Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) - must be specific to pharm industry

- PHD may be considered overqualified

Nice to Have Experience:

- Investigation or product complaint experience

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