Compliance Specialist I (Manufacturing/Quality)

Immediate need for a talented Compliance Specialist I (Manufacturing/Quality) . This is a 12+months contract opportunity with long-term potential and is located in Ridgefield, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-72134

Pay Range: $30 - $34/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• 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.
• Non-Conformance Report (NCR) 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 NCR 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 NCR 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 NCR 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 Requirements and Technology Experience: 

• Key Skills; VEEVA/ATHENA, deviations, NCRs, CAPA
• 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
• 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.
• High School Diploma or GED and 8-10years experience preferred
• Bachelors Degree in Engineering, Life Sciences, or related field (5-7 years experience preferred)
• 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.

Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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