USA Compliance Specialist III Clinical

Employer
Adecco Medical & Science
Location
Framingham, Massachusetts
Salary
Negotiable
Posted
Apr 01, 2024
Closes
Apr 06, 2024
Ref
2741917428
Position Type
Specialist
Hours
Hourly
Work Mode
Hybrid
Employment Type
Contract
Organization Type
Academic, Corporation / LLC
Adecco Medical & Science is hiring a contract Compliance Specialist III for our Pharmaceutical partner in Framingham, MA.

The anticipated wage for this position is between $51 and $53.30. 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

Hybrid role Estimated 1-3 days onsite Local candidates only

Job Requirements:
• Bachelor's Degree
• Close to 5-7 years, the manager will consider more years of experience, however experience must be specific to Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry
• Deviations, change controls, compliance management, pharmaceutical product release experience, CAPA's

Job Duties:

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 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

Pay Details: $52.00 to $53.30 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

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.