Key Responsibilities:
- Ensure compliance with company policies and procedures.
- Support production with process validation and equipment qualifications.
- Assist with complaint investigations, root-cause analysis, and corrective actions.
- Review nonconforming products and recommend dispositions.
- Maintain and distribute QMS documents and records.
- Perform cleanroom monitoring, equipment calibrations, and qualifications.
- Prepare reports, analyze data, and assist in meeting departmental goals.
- 3-5 years of experience in the medical device/pharmaceutical industry.
- Familiarity with FDA regulations preferred.
- great communication, problem-solving, and organizational skills.
- Ability to lift 50 lbs and perform physical tasks.
salary: $60,000 - $70,000 per year
shift: First
work hours: 8 AM - 5 PM
education: High School
Responsibilities
- Complying with company policies, procedures, and training requirements.
- Assisting in the development and implementation of quality assurance policies, procedures, and standards.
- Supporting the Production department with process validation and equipment/facility qualifications.
- Managing complaint processes, including reviewing, investigating, and preparing responses to customer or third-party complaints.
- Assisting in root-cause analysis and corrective actions for complaint investigations.
- Supporting the new supplier approval program.
- Reviewing nonconforming products and recommending disposition.
- Maintaining and distributing controlled documents and records related to the Quality Management System (QMS).
- Writing procedures, work instructions, and specifications for the QMS.
- Performing and documenting cleanroom and warehouse monitoring, qualification, calibration, and re-certification of equipment.
- Preparing reports, analyzing data, and assisting in developing action plans to meet departmental benchmarks.
- Supporting the daily activities of the QA team and ensuring goals and metrics are met.
- Assisting Quality Assurance Associates and performing other related duties as assigned.
The essential functions of this role include:
Skills
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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.
