This is Hema, Staffing Specialist at Intellectt Inc. I am reaching out to you on an exciting job opportunity with one of our direct medical clients. If you are interested, help me with your updated resume. Feel free to contact me on +1-732-683-7973 or Hema@intellectt.com
Role: Quality Control Associate
Location: Scarborough, ME -
Shift Timings: 9pm-7:30am (Sun-Weds)
Job Description
Perform a wide variety of activities to support the Quality Management System.
Conduct product testing, including testing to support complaint investigations and stability verification
Generate product testing results reports
Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production.
Review finished goods batch records.
Report all deviations in these records and assure these have been addressed and resolved prior to issuing approval.
Conduct spot-check inspections/audits of production operations
Participate in the internal audit program
Write, review and approve Standard Operating Procedures (SOPs) as necessary
May assist in supporting the Document Control program, record retention areas, and sample retention areas
May support returned instrument processing
Log returned instruments from the field.
Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
Inspect returned instruments for damage, and performed basic investigation and documenting results prior to second level processing.
As necessary, process instrument documentation for return to the repair facility, and pack instruments as required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
Ability to follow procedures and accurately document results
Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Attention to detail.
Ability to use bleach for cleaning purposes is required.
Education And Experience
Bachelor's degree in a scientific or technical area or equivalent combination of experience and education.
At least one year in a quality assurance role in the medical device industry is preferred.
Best Regards,
Hemanjali Gunimini
Technical Recruiter
Intellectt Inc
Hema@intellectt.com
Desk number: 732-412-6999 | Ext-171
Direct Number: +1 732-683-7973
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Whatsapp, Linked In
In my absence, you may contact My Lead |Tarun Venkat| Direct: +1 (732)-631-8299| venkat@intellectt.com
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Human Resources Services
Referrals increase your chances of interviewing at TekOne IT Services Pvt. Ltd. by 2x