Quality Systems Engineer
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Job Title: Quality Systems Engineer
Location: Portsmouth, NH
Duration: Direct Hire
POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Our client has Validation is in place, for ensuring that all key GMP equipment and systems are validated and maintained to comply with requirements, process framework and international regulatory standards. They're providing Operations, QA, clients, and agencies with accurate, documented evidence that their systems and processes will perform as needed to ensure a quality, compliant manufacturing environment.
- Performs Equipment Validation Maintenance Quality Systems review and re-qualification activities, ensuring GMP equipment continues to be maintained in a validated state. Schedules own tasks to be performed in addition to tasks for Level I and Level II Specialist
- Performs change control assessments for GMP equipment and associated validation activities, ensuring compliance with regulatory requirements
- Programs, organizes, and maintains Validation equipment and supplies and trains new staff in these areas
- Demonstrates a thorough understanding of biopharma manufacturing equipment and validation procedures. Develops validation protocols from Validation plans and engineering documents.
- Provides strong technical expertise- reviews and approves SOPs, protocols, change controls, and deviations
- Performs assigned Quality Systems activities
- Performs other duties as required
- BS and and two+ years of experience in industry.
- Strong understanding of cell therapy manufacturing equipment and validation procedures
- Strong technical writing skills, able to document all work in a meticulous, accurate, and timely manner.
- Strong written and oral communication skills, able to work cross-functionally with minimal supervision in an effective manner to perform daily duties.
- Understands how to write discrepancies and gives a root cause analysis.
- Strong organizational and time management skills
- Experience with Quality Systems
- Able to prioritize tasks as required, in order to support changing business demands
Make this your next career move as one of our many long-term contractors or employees!
Work as our full-time employee with full benefits (Medical, Dental, Vision, STD, LTD, PTO, Retirement, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
ABOUT DIGITAL PROSPECTORS:
Founded in 1999, Digital Prospectors is an award-winning recruiting and consulting firm that specializes in placing contract, contract-to-hire and direct hire engineers into rewarding opportunities with our impressive and ever-growing client base. We believe that all people should love their jobs.
Come see why Digital Prospectors has been voted “Best Staffing Firm to Temp For” by Staffing Industry Analysts, "Best of Staffing" for candidate satisfaction by Inavero / CareerBuilder.com, "Top Temporary Placement Firm" by Boston Business Journal, "Best Company To Work For" by Business NH magazine, "Excellence in IT and Engineering Staffing” by TechServe Alliance, "Top IT Services Company" by Inc. Magazine, "Most Reliable Staffing Agency" in Forbes Magazine and "Top Ranked Staffing Firm" by Staffing Industry Analysts.