What are the responsibilities and job description for the Compliance Specialist position at Akkodis?
Akkodis is seeking a Compliance Specialist with a client in Framingham, Massachusetts (Hybrid).
Rate Range : $50 / hour to $52 / hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
Compliance Specialist
Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of in accordance with cGMPs and Quality directives.
Ensures the efficiency of Quality System implemented between 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 CMOs 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
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at (610 206 0818) or (karan.patel@akkodisgroup.com).
Equal Opportunity Employer / Veterans / Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 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. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https : / / www.akkodis.com / en / privacy-policy
Salary : $50 - $52
