Sr. Specialist Quality Assurance 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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Norwood, Massachusetts
job type: Contract
salary: $45.00 - 56.13 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

The Quality Assurance Sr. Specialist is based in Norwood, MA. This position is part of the company's Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of Quality Control, with a focus on reviewing the following types of documents in support of QC and AS&T: protocols, reports, method SOPs, forms, OJTs, and data tables. The individual will work closely with Quality Control, AS&T, Manufacturing, and other teams.

• Reviews and approves protocols, reports, method SOPs, forms and data tables generated by the Analytical Science and Technology (AS&T) department to ensure compliance and adherence to regulations and cGMP operations.
• Reviews and approves Quality Control (QC) method qualification protocols and reports.
• Reviews and approves Quality Control Stability Protocols and Reports.
• Participates in weekly and monthly walk-throughs to ensure compliance in the laboratories.
• Reviews QC logbooks and alarm responses.
• Works closely with QA teammates to recognize opportunities for improvement within QC.
• Follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Executes tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follows Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Completes training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
• Participates in quality oversight of Quality Control and AS&T.

 
qualifications:

Required

• Bachelor's Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
• 7 - 10 years' experience within a Quality role at a GMP manufacturing environment (combination of Quality Assurance and Quality Control experience preferred).
• Demonstrated strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).

Preferred

• Knowledge of Veeva electronic Document Management System (or equivalent).
• Ability to use and navigate Word, Excel, PowerPoint, and Smartsheets.
• Working knowledge of relevant EU and global regulations and ICH related to GxP's.
• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
• Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
• Ability to conceptualize, analyze, plan, and manage multiple projects in a fast-paced environment.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

 
skills: Quality control, SOP, MS-WORD, 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