QA Inspector Job Description
QA inspector
provides oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements ( FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).
QA Inspector Duties & Responsibilities
To write an effective QA inspector job description, begin by listing detailed duties, responsibilities and expectations. We have included QA inspector job description templates that you can modify and use.
Sample responsibilities for this position include:
Sampling of all raw materials and intermediates according to company standard operating procedure
Performing packaging checks not limited to the following examples
Perform visual and tactile product inspections to identify quality issues
Identifies and reacts to quality-related problems identified by the customer, supplier or from within the company
Transport samples to and from work area with a Powered Industrial Truck (PIT)
Document and initiate the exception process if exception is encountered using the Production Operations Management System (POMS) to research and provide details
Record checks and the result into POMS
Write and submit changes to a Standard Operating Procedure (SOP) document when a process used by the QA Inspector is in need of an update
Enter exception data into a spreadsheet for trending and reporting purposes
Participate in the validation process for new equipment, equipment changes and new processes by performing product testing and reporting on the results
QA Inspector Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Inspector
List any licenses or certifications required by the position: NDE, ASQ, API, CWI, II, QA, PM, AWS, CWB, 9001
Education for QA Inspector
Typically a job would require a certain level of education.
Employers hiring for the QA inspector job most commonly would prefer for their future employee to have a relevant degree such as High School and Associate Degree in General Education, Engineering, Associates, Technical, Education, Supervision, Science, Construction Management, Management, Construction
Skills for QA Inspector
Desired skills for QA inspector include:
GMP documentation and FDA
Quarantine and warehouse operation helpful
Policies and procedures to complete semi-routine tasks
Microsoft Office
Aseptic techniques may be
ISO 9001
MS Office and Inventory Management system are
Mechanical
Application of FDA cGMP’s
Electrical theory
Desired experience for QA inspector includes:
Use of measurement devices such as Calipers, Go/No-Go Gauges, Optical Comparators, Digital Force Gauges and Rulers
Calibrate gauges, rulers, cylinders when necessary using blueprints and calibration equipment
May be designated as an Subject Matter Expert (SME) on an assigned SOP
Notify the supervisor and take appropriate action if any safety, quality or discrepancy issues occur
Requires the ability stand/walk continuously throughout the shift
Must be able to pass the P.I.T
QA Inspector Examples
1
QA Inspector Job Description
Job Description Example
Our company is looking to fill the role of QA inspector. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for QA inspector
- Performs quality assurance related activities on a daily basis including, but not limited to, Inbound Receipt Verification
- Must present information and respond to questions from leads, managers, buyers
- Ability to use hand gauges for inspections
- Enter inspection data in the appropriate computer file
- Put defective product on hold, per the work instructions
- Communicate part / assembly issues noted to the responsible supervisor and / or QA Management
- Document Inspection Results
- Work in a regulated environment with strict adherence to policies and procedures
- Maintain QA files by timely and accurate filing of QA documentation (PO’s, certifications, prints)
- When required, conducts approval of pre-start-up activities including line/room clearance, and initial equipment checks
Qualifications for QA inspector
- Must be able to squat, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance
- Normal visual acuity and the ability to ditinguish color are necessary
- Light work, frequent lifting up to 40lbs
- Must have verbal and written communication skills
- The applicant must have good communication skills, both oral and written
- Capable of communicating quality and engineering criteria/issues to all levels of factory employees, buyers, and suppliers
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QA Inspector Job Description
Job Description Example
Our innovative and growing company is looking for a QA inspector. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA inspector
- Consistently reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP’s and cGMP’s
- Confirms reconciliation/yield data for adherence to specifications and ensures that deviation reports are generated by responsible personnel if out-of-specifications are observed
- Reviews Production logbooks for accuracy and compliance
- Provide real-time guidance to line operations personnel pertaining to compliance to cGMP’s by monitoring dress code, documentation practices, testing methods, and testing accuracy
- Collects data on FPQ and performs release of batch records
- Complies with company policies and procedures and maintains exceptional work attendance
- Performs daily compliance Audit for responsible areas within production
- Responsible for conducting duties in compliance with safety rules, applicable SOP’s, and cGMP Guidelines
- Performs other duties as assigned by Quality Management
- Work from applicable written inspection procedures, drawings, and other pertinent instructions to plan and perform dimensional and visual inspection on parts, tools, gages, and other equipment, accepting material or referring for rework or quality review based on findings
Qualifications for QA inspector
- Blueprint Reading and Statistical Process Control
- Read and perform inspections using the assembly instructions and engineering drawings
- Perform configuration verification and first article inspections on all levels of assemblies
- Verify that all operations have been completely performed and accepted, including acceptance testing
- Prior experience as an inspector is a must
- Experience in the performance of First Article Inspections
3
QA Inspector Job Description
Job Description Example
Our growing company is looking to fill the role of QA inspector. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA inspector
- Use a variety of fixed and variable measuring instruments including computerized machines where program instructions are well defined to check dimensions and recording results
- Follow established procedures to perform in-line checks and verification of dimensions and make sure that operation sheets are being followed
- Recognize need and arrange for repair or replacement of equipment used in performing work as necessary
- Verifies conformance of the product to dimensional specifications
- Release of material based on inspection / test results
- Enters data into the computer for analysis and prepares graphs or charts
- Verifies conformance to gages to calibration standards
- Data entry in to the computer database
- Perform first part on startup
- Conducts inspections of in-process materials and in-process finished products to meet customer specifications
Qualifications for QA inspector
- While performing the duties of this job, the employee may be required to sit or stand for long periods of time
- Operator is required to use computer or touch screen to enter work order data
- Work is generally performed in a demanding fast paced environment in which priorities and instruction can shift daily
- While performing the duties of this job, the employee is regularly required to use SmartScopes, hand tools, and stereoscopes/vision systems, perform repetitive wrist, hand and/or finger movement
- Work schedule hours may change based on manufacturing demand
- Must be able to occasionally move and lift objects of up to 30 lbs
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QA Inspector Job Description
Job Description Example
Our company is looking to fill the role of QA inspector. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA inspector
- Position must work closely with Warehouse leadership and Operations/Production/Manufacturing/Packaging staff to coordinate use of floor space for sampling
- Consistently reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP’s and cGMP’s.Discusses errors directly with line personnel so corrections can be made if required
- Perform in-process and finished goods quality inspections ensuring merchandise meets COMPANY requirements
- Inspect merchandise throughout the manufacturing processes to ensure conformance to all COMPANY requirements
- Participate in corrective action projects and other QA related special activities
- Performance of specific inspections and tests, and specific report preparation
- Performs receiving inspection of incoming material using various measuring devices such as comparators, calipers, micrometers, meters
- Verifies documentation such as picking lists, vendor supplied test data, purchase orders
- Interprets and utilizes inspection procedures, blueprints, schematics, assembly drawings, work orders, specifications, and process documentation to perform quality tasks
- Confers with management, engineering, and production to determine quality and reliability standards
Qualifications for QA inspector
- Well-versed in using measuring equipment such as air spindle gage, micrometer
- The applicant must have good communication skills, both oral and written in English and Chinese
- Capable of communicating quality and ink engineering criteria/issues to all levels of factory employees, buyers, and suppliers
- Prior experience as an inspector is desirable
- Experience using ink quality control equipment, viscometer, particle size analyzer, tensiometer
- High school graduate to college and above
5
QA Inspector Job Description
Job Description Example
Our company is searching for experienced candidates for the position of QA inspector. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QA inspector
- Prepares charts, graphs, reports, and other documentation using various software applications to assist providing a visual and written display of past and current inspection trends to enhance ability
- Work closely with production departments to assure manufactured products maintain conformance
- Follow all EHS rules
- Perform basic work direction of other QA inspectors on a daily basis or as assigned
- Conduct in-process inspections, required internal audits, and accurately report on findings
- Monitor and regulate the assignment and use of calibrated Measuring & Testing Equipment
- Promptly perform the inspection of returned / failed material
- Keep QA Manager appraised of all quality related issues and/or the need to purchase material / equipment
- Provide or assist quality related data entry, statistical gathering, and training of work force crew
- Must be competent in the use of hand measurement tools such as calipers, micrometers, pin gauges
Qualifications for QA inspector
- Ceramic process knowledge
- Minimum of HS Diploma/ GED with 2-3+ years of experience OR TTP or Associates Degree recent graduates
- Prior experience with inspection of production of personal care or related products
- Able to do simple calculations/math without a calculator
- Associate degree with 5+ years of quality related experience or equivalent, (medical device industry experience preferred)
- Knowledge of FDA 21 QSR 820 current ISO standards 13485 (medical device Protocol) domestic and international