Compliance Specialist Position Available In Bergen, New Jersey

Compliance Specialist Aequor Technologies

• 4.1 Ridgefield, NJ Job Details Contract $30
• $37 an hour 7 hours ago Qualifications CGMP Engineering Corrective and preventive actions (CAPA)

GMP ISO 9001

Mid-level Microsoft Office High school diploma or GED Analysis skills Quality assurance Bachelor’s degree Manufacturing Document management systems 2 years Communication skills Non-conformance reporting FDA regulations Full Job Description Title

• Compliance Specialist I (Manufacturing/Quality) 1st

Shift Location:

Ridgefield, NJ Duration:

Contract until May 2026 (Possible extension) JD•

Onsite Education:

BA in Pharmaceuticals, Bio-chemistry, Microbiology Must-Have Experience with: VEEVA, ATHENA, deviations

Preferred Experience:

attention to detail, planning, SOP updates & reviews, team collaboration and independent work

Other:

BA + minimum of 2 years relevant experience 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.
• Analyze 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.
• Analyze 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 analyze data and identify trends or areas for improvement.

Education:

• High School Diploma or GED and 8-10years experience preferred
• Bachelors 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

MINAKSHI SANGWAN

Recruiting Lead

• US Recruitment

O 732-339-3518 E W

http://www.aequor.com/

Job Type:

Contract Pay:

$30.00

• $37.

00 per hour

Schedule:

8 hour shift Monday to

Friday Work Location:

In person