Compliance Specialist I

Job Title: Compliance Specialist I
Location: Ridgefield, NJ
Contract: 12+ Months (Possible of extension)

Pay Rate: $33.00 - $35.00/Hour. on W2
 
Top Skills Required:

• Education: BA in Pharmaceuticals, Biochemistry, Microbiology
• Must-Have Experience with: VEEVA, ATHENA, deviations
• Preferred Experience: attention to detail, planning, SOP updates & reviews

 
Job Description Summary:
The Compliance Specialist is responsible to support Manufacturing by investigating, authoring, and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. Assign corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address issues identified throughout production. Work with cross-functional teams, including production, quality control, quality assurance and facilities , to ensure efficient problem-solving and resolution of non-conformance issues. Communicate findings, actions, and improvements to relevant stakeholders and management.
 
Key Responsibilities:
Non-Conformance Report (Client) Management:

• Investigate both significant and non-significant NCRs for production and EM events.
• Analyse data and identify the root causes to ensure a thorough investigation and identification of underlying issues.
• Write and maintain comprehensive Client reports, including all necessary details such as cause, impact, and actions taken.

 
Corrective and Preventative Actions (CAPA):

• Work closely with cross-functional teams to develop and implement corrective and preventative actions in response to Client findings.
• Ensure CAPAs are well-defined, actionable, and address the root cause effectively.
• Monitor and track the progress of CAPAs, ensuring timely resolution and documentation of outcomes.

 
Effectiveness Checks (EC):

• Conduct effectiveness checks (ECs) to assess the success of implemented CAPAs and Client resolutions.
• Analyse the results of effectiveness checks to ensure that corrective actions have been effective in preventing recurrence.
• Recommend further adjustments to CAPAs if necessary, based on the effectiveness checks.

 
Key Competencies:

• Attention to detail and thoroughness in investigation.
• Ability to work independently and manage multiple tasks simultaneously.
• Strong collaboration and interpersonal skills to work across teams.
• Ability to analyse data and identify trends or areas for improvement.

 
Education:

• High School Diploma or GED and 8-10 years’ experience preferred
• Bachelor’s degree in engineering, Life Sciences, or related field (5-7 years’ experience preferred)

 
Qualification:

• 2+ years of experience in manufacturing, quality assurance, or related fields, with experience in managing NCRs, CAPAs and ECs.
• Knowledge of industry regulations such as GMP, ISO 9001, and FDA guidelines.
• Strong analytical, problem-solving, and investigative skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite and document control software.