Location
Worcester, MA | United States
Job description
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. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: Worcester, Massachusetts
job type: Contract
salary: $75.00 - 108.98 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provide Quality Assurance oversight and assessment of operational activities in Production, Compliance, Validations, and Technical Services projects.
- Serve as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories, BT, Manufacturing, and Engineering.
- Ensure process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes.
- Review and approve equipment validation documentation (e.g., protocols, deviations, and final reports).
- Support change control activities associated with processes and equipment validations.
- Manage and coordinate QA support for new and existing process equipment validations implementation.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
- Ensure investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses for plant events and places product on QA hold where appropriate.
- Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
- Develop and implement statistical quality programs and process monitoring systems.
- Support investigations related to process and testing findings.
- Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPA's, compliance, complaints process.
- Perform other duties as assigned.
qualifications: - Bachelor's degree, preferably in Biology, Chemistry or Engineering.
- 6+ years of overall experience in Manufacturing, Quality or Engineering.
- Experience in pharmaceutical GMP regulated environment preferred.
- Experience in aseptic manufacturing environment preferred.
- Knowledge of quality / compliance management, as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.
- Good verbal/written communication skills. Good problem solving and analytical skills.
- Demonstrated ability to apply analytical methods and work with all levels of Management.
- Detail-oriented and self-motivated.
skills: CMC, SOP, Quality Assurance, 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
[email protected].
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).
Applications accepted on ongoing basis until filled.
Job tags
Salary
