STAFFING SYNERGIES is currently looking to fill Quality Auditor.
We are looking to fill positions for the following shifts:
- 1st Shift - Monday- Friday 7:00 am to 3:30 pm
Position Details
Position Title: Quality Auditor
Department: Quality
Position Purpose: The Quality Auditor is responsible for ensuring that all products are produced according to the appropriate specifications and meet all quality and customers standards. Under the supervision of the Quality Lead and Quality Supervisor performs quality assurance functions to ensure compliance with internal and external regulations and procedures.
Required Skills:
- Knowledge of FDA regulations, cGMP regulations
- Ability to work with all levels of management and personnel within the organization
- Ability to work independently to manage multiple tasks simultaneously.
- Flexibility and awareness of production
- Problem solving skills
- Work under pressure.
- Adjust to immediate changes.
- Works in a team environment
- Good Communication Skills
The following duties are normal for this position. The incumbent may perform some or all of these duties; however, it is not an exclusive or all-inclusive list. Other duties may be assigned.
Essential Duties and Responsibilities
- Works closely with Production and Quality Management to resolve significant Quality issues in a timely manner which may require real-time and/or follow up activities.
- Authorized to place in “Block Status” production operations when situations warrant and recommends remediation activities.
- Ensures quality activities are performed in conformance to requirements following GMPs, SOPs and customer requirements.
- Read Job Specifications and reviews the First Article
- Compare all product and component against the Bill of Material (BOM)
- Perform Acceptance Quality Limits (AQL) inspections to production lines to ensure the production is being performed as per requirements, as well as communicates with Production Line Leaders of any issues observed on the line during inspection process.
- Performs quality inspections as required; confirms date codes, lots, expiration dates, and all other customer specific requirements. As well as ensures lot # and Expiration Dates are always visible and Legible
- Record inspection in the Quality Report
- Monitor the adherence to Validation, Qualification and Trial Protocols
- Conduct Electronic Label Vision Challenges 3 times during production (Beginning / Middle/ End) if required.
- Record Electronic Label Vision Challenges (ELV) on the Electronic Label Vision Challenge Report.
- In the event that production must be inspected on the line due to a discrepancy, the Quality Auditor must supervise the inspection.
- Place any non-conformance materials in quarantine.
- Notify Quality Lead of all deviations and/ or Non-Conformances discovered during inspections.
- Monitor all lot changes to ensure compliance with the lot breakdown.
- Monitor batch records for timeliness and accuracy.
- Completes proper documentation of quality performance.
- Performs random checks on finished goods to ensure compliance.
Required Functions
- Maintain goals given
- Ensure proper tools are obtained to perform the job
- Follow GMP and company’s policies
- Review documentation to ensure is accurate and based on GMP requirements
- Work with other departments (Production/Inventory/Logistics)
Minimum Qualifications
- Minimum 5 years of applicable GMP experience in a QA position and/or equivalent years’ experience in a related field also considered as deemed appropriate by QA Management and/or High School Diploma/GED.
Preferred Qualifications
Physical Requirements & Work Environment
- Required to stand up to 8 plus hours a day
- Must be able to lift up to 25 lbs. on occasion
- Must be able to reach, squat, stoop, bend
- Must have physical dexterity of hand and fingers
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis and not comprehensive of all possible job responsibilities, tasks, and duties. It does not exclude other duties as assigned. It is also the responsibility of the individual to follow the safety guidelines in the work place and ensure quality expectations are met.
Job Type: Full-time
Pay: From $17.00 per hour
Benefits:
- Health insurance
- Paid time off
Work Location: In person
