Join the teams who innovate, support, and deliver diagnostic and manufacturing solutions made for and by scientists! Our client is breaking ground on a new facility before the end of the year, making now the perfect time to get into this well-know company and grow with them as they expand their footprint and service offerings! Did we mention there is free breakfast every Monday?!?
This position is to coordinate and lead activities supporting the successful maintenance of quality management systems (QMS) under ISO9001:2015, ISO13485:2016, and 21 CFR 820. Create and manage documentation related to the QMS. Participate in all quality related activities for both the Life Sciences and Diagnostics divisions.
Applicants do not need to advise up on QA policy, we are looking for someone who can provide bandwidth to deal with customer audits.
- Seasoned QA professional with ISO 9001 experience. ISO 134585 would also be nice but not necessary.
- Familiarity with Root cause , CAPAs.
- Could use experience with GMP/pharma
- 3-6 mos, don't need the experience, don't need guidance, need the bandwidth.
- Should be able to type pretty fast.
- Not working with customers.
location: Solon, Ohio
job type: Temporary
salary: $21.50 - 28.80 per hour
work hours: 9 to 5
- Trouble Reports (product complaints): Coordinate the assignment of trouble reports, assist in the resolution of events, perform root cause investigation for those assigned to QA, and lead the recurring trouble report resolution meeting
- CAPA: Coordinate the assignment of CAPAs, assist in the resolution of events, perform root cause investigation for those assigned to QA, and lead the recurring CAPA meeting.
- Training: Coordinate initial QMS training for new hires, assist all departments to manage employee training in ISOXpress, coordinate refresher training, and present quality related training (as needed)
- Documentation: Coordinate and manage documents and records in ISOXpress, and perform QA review of records and documents
- Change control: Perform QA review of product and process change requests, and coordinate retention of the resulting records and supporting documentation
- Nonconforming product: Assist all departments to identify, investigate, document, and resolve nonconformity events
- Customer Satisfaction: Assist with customer satisfaction survey administration
- Quality Management Review: Assist to gather information supporting the quality management review process
- Internal Audit: Coordinate the audit schedule and resource assignment, perform as lead and supporting auditor for various QMS elements, assist departments to resolve audit findings, and coordinate resulting records and supporting evidence in ISOXpress
- 3rd Party Audits: Participate in QMS audits of Company by regulators, customers, or registrars (ISO certification and surveillance audits)
- Continual Improvement: Assist in the creation, revision, and implementation of procedures, forms, and work instructions to improve current processes
- Quality Oversight: Perform QA checks of operations activity including label verification and records review
- Supplier Quality: Support supplier qualification activities including audits, change control, and information inquiries
- Customer Requests: Assist in responses to quality related customer requests or inquiries including surveys, questionnaires, forms, letters of certification/declaration, evidence of registration, licensing, etc.
- Prepare for and participate in all QA-related activities.
- All other duties as assigned
- Bachelor's degree required
- Educational focus in science or engineering
- Experience within a regulated industry
- Experience within a QMS certified to an ISO standard
- Strong written and verbal communication skills
- Strong computer skills with Microsoft Office products
- 3-6 months, don't need the experience, don't need guidance, need the bandwidth.
skills: Quality Assurance, CAPA
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.
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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).
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