Manufacturing Quality Inspector

Job Description

Job Description

Location: Durham, NC
Start Date: Candidates must be available to start on a Monday for orientation and training
Duration: 8 weeks initially, with the possibility of extension

Training Requirement:
Candidates must be available for first-week training on day shift between 8:00 AM–4:00 PM.

Shift Hours:

• 2nd Shift: 2:45 PM–11:00 PM

Work Environment & PPE:
The work will be performed in a clean-space manufacturing environment. Company-provided PPE will include safety glasses, hearing protection, lab coats, hair nets, beard covers, and safety shoes as needed. Candidates who already have their own safety shoes should bring them to the site.
Candidates must be comfortable following all clean-space, safety, PPE, and contamination-control requirements.

Physical Requirements:
This is an onsite manufacturing position and candidates should be comfortable with the physical demands of the role, including:

• Ability to stand and/or walk for extended periods throughout the shift
• Ability to perform repetitive tasks while maintaining attention to detail
• Ability to bend, reach, and move throughout the work area as required
• Ability to wear required PPE for extended periods
• Ability to work in a controlled clean-space manufacturing environment

Vision Requirement:
A vision test will be conducted onsite. Candidates should wear their prescription glasses or corrective lenses for the test, if applicable.

Job Description
Performs in-process and final inspection of multiple products prior to shipment to the customer using internal visual inspection techniques. Accepts or rejects product according to inspection criteria. Reports issues to supervisor and records findings on inspection documents.

Description of Work
This position includes significant duties such as:
Ensures that process and quality inspections are recorded in correct designated forms based on product manufactured. Information on these documents need to be traceable and correct, this would include process parameters, gauge calibration ID number, lot/batch number, item/sku number, date and that it follows proper good documentation practices (GDP) throughout the document.

Procures inspection samples from in-process or finished products as stated on the inspection documentation. This may require removal of cartons from skids/pallets, replacing samples with product obtained from the operator stations, re-taping cartons, and replacing them on skids/pallets. Inspects labels, lot numbers, count, and packaging configuration for compliance to specifications.

Rejects defective product and notifies manufacturing supervisor and quality technician. Writes a Non-Conformance Material Report (NCMR), coordinates with Operation to pull suspected product off skid/pallet and ensures it properly located it to rework or quarantine area. Responsible for identifying each skid/pallet of questionable product. When rework is complete, re-audits for acceptability.

Writes information about each product in a daily log to be used as a reference for inspectors on other shifts (if applicable).

May be asked to help with the inspection and testing of validation samples, raw materials and/or incoming inspections.

Maintains a clean and safe work area. Follows GMP and ISO regulations and company policies and procedures.

Ensure adherence to plant quality standards.
Performs other Quality-related duties as assigned.

Minimum Qualifications:
High School Diploma or GED required.
Must possess a minimum of 1yr MFG and inspection experience.

Skills/Experience:
Must be capable of working in a team environment.
Must be able to read and understand standard operating procedures, and other manufacturing work instructions and forms.
Must be able to perform simple math calculations, e.g. addition and subtraction.
Participation in regular on-the-job training regarding product, cGMP/Quality, equipment, processes, performance, and any changes that impact daily production.

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