What are the responsibilities and job description for the Quality Control Specialist position at MRK Tech Solutions?
Company Description:
MRK Tech Solutions is at the forefront of innovation, collaborating with industry leaders and actively engaging in research and development to deliver cutting-edge solutions. With a proven track record of success, we address not only today’s challenges but anticipate the needs of the future. Our mission is to create tangible, real-world impact by implementing technologies and strategies that drive meaningful change.
Work Hours:
The normal working day is 9:00 a.m. to 5:00 p.m., Monday through Friday. Variations of the usual workweek may be used to maximize human and budgetary resources. Executive Management and on-call personnel may be contacted at any time to respond to routine or emergent needs.
Expected hours of work: 40 hours in office work week. Typical hours are M-F 9am-5pm but may flex based on the needs of the business
Role Description:
The QC Specialist, as part of the QC department, is responsible for ensuring that products or services meet specified standards by defining and enforcing quality processes, conducting inspections and audits, monitoring performance data, and implementing corrective actions. Their work includes inspecting raw materials and in-process components, as well as performing final product assessments, thereby improving efficiency, reducing costs, ensuring regulatory compliance, and enhancing customer satisfaction.
Essential functions and responsibilities:
Maintain compliance with ISO 9001, ISO 13485, and ISO 17025
Assist in defining and enforcing quality processes
Conduct inspections and audits per established procedures
Monitor performance data
Implement corrective actions as appropriate
Inspect raw materials, in-process components, and finished goods
Identify, Segregate and document nonconforming products
Perform basic PM of various equipment
Observe good housekeeping in performance of job duties
Other duties: Miscellaneous tasks as assigned
Qualifications:
Required education:
This is an entry level position requiring a High School Diploma or equivalent. Bachelor’s degree in any science discipline, preferred
Experience:
Commercial QC experience of 2 years, preferred but not required
Skills:
The following skills are required for this role:
Ability to read, write and speak English at an advanced level
Strong attention to detail and ability to think strategically and tactically
Ability to sit, stand, bend, crouch, reach and lift 20 lbs.
Ability to understand the hazards associated with assigned work and abide by established procedures in handling and use of materials
Familiarity with MS Office Suite especially Word and Excel
This is an entry level position; the following skills are preferred but not required as training will occur:
QC experience
cGMP and cleanroom operations experience
Knowledge of environmental monitoring in cGMP environments
Experience with Good Documentation Practices
Experience training others
Root cause analysis and CAPA experience
Regulatory Affairs experience
Special physical demands and/or hazards:
Lab and office environments, repetitive motions, awkward postures, manual handling, thermal hazards (Ultra-low freezers, CO2, N2, LN2, etc.), sharps, biowaste, chemical exposures, continuous noise from HEPA filtration
Must be able to sit, stand, bend, crouch, reach and lift 20 lbs