Location: Buena, NJ
Responsible for overseeing of Quality Assurance in Topical areas for packaging and compounding and the Sterile Manufacturing suite.
- Oversee the activities in the sterile manufacturing and packaging areas. Assisting in all activities as required and reviewing documentation when needed.
- 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 nonconformance incidents to Packaging Supervision and Quality Assurance Management.
- Establish scope of con conformance units and determine remediation plans with manufacturing personnel.
- Conduct packaging terminal audit of finished goods.
- Aid in Investigations for product non conformation.
- 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 for the pharmaceutical industry.
- Minimally 1 year experience in working with Sterile Manufacturing or Injectables.
- 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.
- Physical Demands
- Ability to lift
- Available to work second shift as required.
- Inside and outside work
- Move between buildings
- Temperature variations
- Sit and stand for long periods
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs