Adecco Healthcare & Life Sciences is hiring a contract Quality/Regulatory Compliance Specialist for our Pharmaceutical partner in Framingham, MA. The anticipated hourly wage for this position is between $52 and $53.31. Hourly wage may depend upon experience, education, geographic location, and other factors. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria **Local candidates only, Hybrid Role, One-year Contract** · Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities in accordance with cGMPs and Quality directives. · Ensures the efficiency of Quality System implemented between the 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 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 **Type and Length of Experience** · Bachelor of Science 5-7 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry **Pay Details:** $52.00 to $53.31 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance