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Location

Worcester, MA | United States

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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: $45.00 - 52.69 per hour
work hours: 9 to 5
education: Bachelors



responsibilities:

• Assists with planning and conducting internal compliance audits of all operations within the facility.
• Hosts external auditors during site inspections
• Provides support with company and regulatory agency (i.e. DEA, FDA) inspections
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Assist with management review and associated metrics for the plant
• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's)
• Supports/leads product significant events and market action activities and drafts/reviews all necessary documentation and correspondences between Company-Branchburg, corporate, and regulatory agencies as required.
• Manages the assessment process for new or revised external standards/regulations for applicability and impacts to the Branchburg Quality Management System (QMS) and products. Reviews/approves assessments completed by other functional areas.
• Supports/Leads Quality assessments of major product/process changes or new markets. Identifies and communicates compliance risks to management to ensure appropriate actions are taken to remediate gaps or areas for improvement. Complete customer surveys as needed.

qualifications:

• Bachelor's degree, preferably in science or Engineering, or equivalent work experience is required
• 3+ years of experience in medical devices, Experience with Class II and/or Class III medical device
• Experience coordinating recall/market actions
• Quality Assurance/Regulatory Affairs/Compliance preferred
• Knowledge of regulations and standards preferred
• Ability to evaluation quality, production and support areas for compliance to GMPs
• Ability to identify and investigate problems and help to resolve them
• Excellent verbal and technical writing skills with the ability to interface effectively cross-functionally and at all levels.
• Demonstrated leadership skills.

skills: SOP, Quality Assurance, CAPA, 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.

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Job tags

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Salary