Compliance Specialist
Compliance Specialist Job Type:
Direct Hire Compensation:
$70-75k Location:
Caldwell, NJ Compliance Specialist Overview:
Our client is a trusted partner to leading companies in the healthcare industry.
They provide clients with labeling and packaging options as well as comprehensive supply chain solutions.
Under the direction of the Manager of Compliance and Regulatory Affairs, the Compliance Specialist ensures compliance with regulatory requirements (FDA CFR 210-211) governing the filling, packaging, labeling, warehousing, and distribution of products related to the MP portfolio.
Compliance Specialist
Responsibilities:
Essential Functions:
Clearly communicate compliance strategy and rationale, both verbally and in written communications.
Support compliance functions such as inspection readiness/remediation activities, generation of Key Indicators for performance and compliance monitoring, and continuous improvements Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
Support quality system programs such as Deviation, CAPA, and Change Management.
Conduct internal and customer investigations and root cause analysis.
Update and revise MP site SOPs.
Assess company operations to identify compliance risks.
Advising management on updated regulations and policies.
Updating policies and procedures based on changing regulations and laws.
Provide support on a variety of complex regulations while monitoring policies, procedures.
Prepare and filed reports to government agencies to ensure compliance.
Track and maintained deadlines and filing dates.
Monitor projects and regulatory agencies reporting requirements.
Nonessential Functions/Demands:
Assist with FDA and other regulatory agency inspections as needed.
Perform other related duties as assigned.
Actively participate in process improvement efforts.
Report KPIs monthly.
Qualifications/Requirements:
1-3 years' experience in compliance and Bachelor's degree (preferred not required) Strong knowledge of FDA regulations Minimum of Associates degree and related experience Ability to effectively organize and manage multiple projects simultaneously Ability to communicate effectively with all levels of management and employees Knowledge and understanding of FDA CFR 210-211 cGMP regulations.
Excellent attention to detail Excellent verbal, written, and interpersonal communication skills.
Excellent Word and Excel skills.
Analytical skills Problem-solving and decision-making skills Efficiency in dealing with internal and external customers Ability to work in a team Positive attitude.
Can work with minimal supervision.
Advocate for Quality and resolve issues within the scope of responsibilities.
Must have great administration / organizational skills with the ability to work efficiently in a dynamic work environment.
Must be self-motivated and able to work independently with a team-focused attitude.
Compensation / Pay Rate (Up to):
$70,000.
00 - $75,000.
00 Per Year Recommended Skills Administration Analytical Attention To Detail Business Process Improvement Certified Global Meeting Planner Change Management Estimated Salary: $20 to $28 per hour based on qualifications.
Direct Hire Compensation:
$70-75k Location:
Caldwell, NJ Compliance Specialist Overview:
Our client is a trusted partner to leading companies in the healthcare industry.
They provide clients with labeling and packaging options as well as comprehensive supply chain solutions.
Under the direction of the Manager of Compliance and Regulatory Affairs, the Compliance Specialist ensures compliance with regulatory requirements (FDA CFR 210-211) governing the filling, packaging, labeling, warehousing, and distribution of products related to the MP portfolio.
Compliance Specialist
Responsibilities:
Essential Functions:
Clearly communicate compliance strategy and rationale, both verbally and in written communications.
Support compliance functions such as inspection readiness/remediation activities, generation of Key Indicators for performance and compliance monitoring, and continuous improvements Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
Support quality system programs such as Deviation, CAPA, and Change Management.
Conduct internal and customer investigations and root cause analysis.
Update and revise MP site SOPs.
Assess company operations to identify compliance risks.
Advising management on updated regulations and policies.
Updating policies and procedures based on changing regulations and laws.
Provide support on a variety of complex regulations while monitoring policies, procedures.
Prepare and filed reports to government agencies to ensure compliance.
Track and maintained deadlines and filing dates.
Monitor projects and regulatory agencies reporting requirements.
Nonessential Functions/Demands:
Assist with FDA and other regulatory agency inspections as needed.
Perform other related duties as assigned.
Actively participate in process improvement efforts.
Report KPIs monthly.
Qualifications/Requirements:
1-3 years' experience in compliance and Bachelor's degree (preferred not required) Strong knowledge of FDA regulations Minimum of Associates degree and related experience Ability to effectively organize and manage multiple projects simultaneously Ability to communicate effectively with all levels of management and employees Knowledge and understanding of FDA CFR 210-211 cGMP regulations.
Excellent attention to detail Excellent verbal, written, and interpersonal communication skills.
Excellent Word and Excel skills.
Analytical skills Problem-solving and decision-making skills Efficiency in dealing with internal and external customers Ability to work in a team Positive attitude.
Can work with minimal supervision.
Advocate for Quality and resolve issues within the scope of responsibilities.
Must have great administration / organizational skills with the ability to work efficiently in a dynamic work environment.
Must be self-motivated and able to work independently with a team-focused attitude.
Compensation / Pay Rate (Up to):
$70,000.
00 - $75,000.
00 Per Year Recommended Skills Administration Analytical Attention To Detail Business Process Improvement Certified Global Meeting Planner Change Management Estimated Salary: $20 to $28 per hour based on qualifications.
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