Massachusetts Veterans Jobs

associate i, quality control compliance/data review.

• norwood , massachusetts

• posted july 8, 2024

job details

summary

• $25 - $32.26 per hour

• contract

• high school

• category life, physical, and social science occupations

• reference48414

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. 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: $25.00 - 32.26 per hour

work hours: 3 to 11

education: High School

responsibilities:

The Quality Control Microbiology Compliance Data Review Associate I is responsible for the review and verification of microbiological data to ensure accuracy, compliance with regulatory standards, and adherence to company policies. This role plays a crucial part in maintaining the integrity of the quality control process and ensuring the safety and efficacy of products.

Data Review:

• Review microbiological test data for accuracy, completeness, and compliance with GMP (Good Manufacturing Practices) and company SOPs (Standard Operating Procedures).

• Verify calculations, data entries, and test results for microbiological assays including but not limited to bioburden, endotoxin, sterility, and environmental monitoring.

• Ensure that all data is recorded and reported according to regulatory requirements and company standards.

• Follow 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.

Documentation:

• Maintain accurate and detailed records of all data reviews.

• Prepare and review Certificates of Analysis (CoA) and other quality documentation.

• Ensure all documentation is audit-ready and complies with regulatory standards.

Compliance:

• Ensure compliance with FDA, EMA, and other regulatory agencies' guidelines.

• Participate in internal and external audits and inspections as needed.

• Identify and report any deviations or non-conformances in the data and collaborate with the QC team to resolve them.

Continuous Improvement:

• Assist in the development and implementation of quality control procedures and policies.

• Participate in continuous improvement initiatives to enhance data review processes and overall quality control.

Collaboration:

• Work closely with the Quality Assurance, Production, and R&D teams to ensure seamless communication and coordination.

• Collaborate with the QC Microbiology team to ensure timely and accurate data review.

Physical Requirements:

• Ability to sit or stand for extended periods.

• Ability to work in a laboratory environment with exposure to biological and chemical hazards.

qualifications:

• High School Diploma

• Previous experience in the biotechnology/biopharmaceutical industry, or other regulated industry a plus

• Experience in biopharmaceutical & GMP.

• Strong attention to detail and analytical skills.

• Excellent written and verbal communication skills.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• Ability to work independently and as part of a team.

• Strong organizational and time management skills.

skills: Quality control, SOP, MS-WORD, MS-EXCEL, MS-Powerpoint, Microbiology, 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.