Compliance Specialist, Quality Assurance - QA​/QC

Job 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.

• 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.

• 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.
• 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.

• High School Diploma or GED and 8-10 years  experience preferred
• Bachelor s Degree and 3-5 years  experience preferred
• Proficiency in using Microsoft Excel and Word

• 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.

• 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.

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
• The individual must support all company and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

Skills Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Food and Drug Administration (FDA)

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate s education, work experience, work location, specific job duties, certifications, etc. Randstad offers a comprehensive benefits package, including medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.