Location: Buena, NJ
- Review pre and post manufacturing and packaging records to ensure compliance with cGMPs and company standards.
- Conduct daily balance functionality checks in packaging.
- Conduct Line Clearance inspection and provide Line Clearance in conjunction with packaging personnel.
- Conduct Hourly/semi hourly finished goods attribute checks, weight checks, torque checks, seal integrity. Record as per Fill and Assembly Specifications.
- Perform AQL inspections on finished product as needed.
- Pull finished goods samples as per Fill and Assembly Spec. Deliver to Labs. Record as per SOP.
- Report OOS incidents to Packaging Supervision and Quality Assurance Management.
- Establish scope of OOS units and determine remediation plans with manufacturing personnel.
- Conduct packaging terminal audit of finished goods.
- Aid in Investigations for Product OOS.
- Conduct re-inspection of packaging line after foreign find.
- Assist in review of pre-approval for filling batch records.
- Assist in the maintenance of related SOPs related to quality inspections.
- Collect and prepare all final packaged customer samples.
- Keep Manager informed of all key quality findings and issues.
- Assumes other activities and responsibilities from time to time as directed.
- HS Diploma and minimum of 1-2 years of experience in QA/QC, or equivalent experience.
- Solid demonstrated ability to work on multiple projects and meet timelines.
- Strong knowledge of cGMP requirements.
- Practical experience with document control and QA support of manufacturing.
- Excellent organizational skills.
- Demonstrated ability to work on multiple projects and meet timelines.
- Detail oriented.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.