Compliance Specialist III
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location: Framingham, Massachusetts
job type: Contract
salary: $23.86 - 28.07 per hour
work hours: 9 to 5
o Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities in accordance with cGMPs and Quality directives.
o Ensures the efficiency of Quality System implemented betweenthe 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.
o Support the External Manufacturing North America Audit Program by working with and conducting contractor audits to assure compliance to Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings.
o Support projects as assigned such as new product launch teams.
o Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to company products.
o Participates with subcontractors to find solutions concerning quality issues.
o Respond to customer complaints, including close out and determination of corrective actions.
o Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations.
o Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality.
o Ensure the compliance of the activity to all laws and in preparation of Quality Agreements.
o Excellent oral and written communication skills in cGMP documentation.
o Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience
o Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship
o 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
o Thorough knowledge of GMP's and regulatory requirements (including Sarbanes Oxley)
o Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations
o Project management skills
Type and Length of Experience:
o Bachelor of Science
o 3-5 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in thePharmaceutical or related regulated indust
skills: SOP, CAPA
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.