Regulatory Compliance Specialist

Location: Edison, NJ
Job Code: 966
# of Openings: 1

Description

Position Summary:

 

The Compliance Specialist performs activities to ensure quality and compliance with applicable internal and regulatory requirements. These activities may include conducting internal audits, hosting customer audits and health authority inspections, and maintaining quality metrics as part of the Quality Management System.  As a subject matter expert, the role holder will create (or assist with the creation of) the applicable Quality Management System documentation such as SOPs, training materials or investigation reports. Depending on experience, may serve as the lead auditor for external audits as well.  

This role will also support the Regulatory Affairs team, as necessary, in filing various regulatory documentation and may be required to interact with US and international regulatory authorities.

Key Job Responsibilities: 

  • Performs internal and external quality audits and/or inspections. May serve as Lead Auditor for external audits.
  • Hosts client audits and inspections.
  • Support the supplier quality/vendor management program for the site.
  • Develop, analyze, and present quality metrics.
  • Track and facilitate investigations and CAPAs to address service/product complaints. 
  • Ability to facilitate training, investigations and internal audits for all components associated with data integrity (paper and electronic records).  Role holder must be able to determine gaps and develop the necessary plans to remediate identified issues.

 

General: 

  • Provide and receive training.
  • Assists with development of SOPs or other quality documents as needed.
  • Perform job responsibilities independently with limited supervision.
  • Complies with company polices and SOPs.
  • Effectively performs duties, on schedule, with accuracy and competency.
  • Maintains accurate files and records.
  • Serves as an effective member of the Compliance team.  Works the hours necessary to meet scheduling commitments, is punctual with minimal absenteeism.
  • Travel: Some domestic and international travel may be required.
  • Remain current with applicable regulations, regulatory thinking, and guidance documents.
  • Performs other duties as assigned.

 

Essential Job Requirements:

 

Education/Experience

  • Bachelor’s degree in Chemistry, Biology, or related scientific field with 3+ years GMP-related experience or Master’s degree in related field with 1+ years related experience, or equivalent educational and work experience. No certifications are required. No FDA debarment.

We invite all qualified applicants to apply. We offer competitive salary, a comprehensive benefits package and opportunity for advancement.

Alcami is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.





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