The Micro QC Scientist I is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing direction, mentoring and completing high level projects for the Micro team. This position also includes product testing, release EM Monitoring, data review and validation.
location: Ridgefield, New Jersey
job type: Contract
salary: $42 - 45 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Exceptional knowledge of USP, EU and ISO regulations a must.
- The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays
- Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
- Validation protocol writing, review and execution (or over seeing validation execution)
- SOP review, creation and approval
- OOS investigations writing/review and approval.
- Mentor junior Analysts on testing, trouble shooting and Lab related items
- Ensure compliance with all cGMP standards, safety and environmental regulations and company SOPs.
- Provide advice to subordinates based on general policies and management guidance.
- Ensure that high level projects are completed on schedule and accurately.
- Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
- Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.
- Support regulatory, third party and internal audits when required
- Conveys complex information in a concise manner
- Motivate and Develop teams
- Interact with Project Teams and cross-functional groups related to site operations
qualifications:
Required:
- BA/BS in Microbiology/Biology with 6-10 years' experience is required
- Understanding of validation testing; write, execute and report validation studies
- Experience with microbiology techniques
- Experience writing protocols, data review, authoring SOPS, Change Controls, out of specification investigations and report writing
- Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing
- Experience with a deviation/CAPA enterprise system
skills: Biology, Microbiology, SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (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.
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: 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.
