Cynet Systems · 1 week ago
Quality Control Scientist
Ridgefield, NJ
Full-time
Onsite
Senior Level
6+ years expCynet Systems is a company specializing in quality control within the pharmaceuticals sector, and they are seeking a Quality Control Scientist. The role involves ensuring compliance with regulatory standards, mentoring junior analysts, and overseeing various quality control processes including validation and investigations.
EmploymentRecruitingStaffing Agency
Responsibilities
Exceptional knowledge of USP, EU and ISO regulations is 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
Participate in Change Control meetings as the Microbiology Subject Matter Expert and initiate 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
Qualification
Required
Exceptional knowledge of USP, EU and ISO regulations is 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 overseeing validation execution)
SOP review, creation and approval
OOS investigations writing/review and approval
Mentor junior Analysts on testing, troubleshooting 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
Participate in Change Control meetings as the Microbiology Subject Matter Expert and initiate 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
Education / Experience Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours
BA/BS in Microbiology/Biology with 6-10 years of experience is required
A thorough understanding of validation testing
Write, execute and report validation studies
Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold
Prior experience with 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
Excellent technical writing skills
Ability to collaborate effectively with personnel and between departments
Strong analytical and problem-solving skills
Make sound judgement from data
Strong communicator
Works independently
Working knowledge of Word, Excel and PowerPoint
Preferred
Preferred experience with a deviation/CAPA enterprise system
Company
Cynet Systems
Headquartered in Washington DC Metro Area, Cynet Systems is a top talent supplier for companies across North America.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashwani (Ash) M.
Partner and Co-CEO
Nikhil "Nick" Budhiraja
Founder / Co-CEO
Company data provided by crunchbase