job summary: As the world's 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! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. location: Framingham, Massachusetts job type: Contract salary: $22.00 - 27.67 per hour work hours: 8 to 4 education: Bachelors responsibilities: ? Ensures the efficiency of Quality System implemented between company and the sub- contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements. ? Leads projects as assigned such as new product launch teams. ? Identify and leads the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to company products. ? Collaborates with subcontractors to find and implement solutions concerning quality issues. ? Respond to customer complaints, including close out and determination of corrective actions by collaborating with CMO's and identifying trends. ? Identify and prevent or resolve issues that could impact the continuity of supply of existing products. ? Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations. Identify trends to reduce Quality anomalies. ? Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality. Knowledge/Competencies ? Excellent oral and written communication skills in cGMP documentation. ? Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience ? Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship ? The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations ? Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations ? Project management skills qualifications: ? Bachelor of Science ? 5-7 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry skills: 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.