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Shift: 1st shift, Mon-Fri 9am-5pm
location: Ridgefield, New Jersey
job type: Contract
salary: $25.50 - 30.00 per hour
work hours: 8 to 4
education: High School
responsibilities:
Description:
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 (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.
- Recommend further adjustments to CAPAs if necessary, based on the effectiveness checks.
qualifications:
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.
- 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.
skills: Quality control, MS-WORD, MS-EXCEL, GMP (Good Manufacturing Practice)
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 HRsupport@randstadusa.com.
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. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
