Quality Support

Praxis Packaging•Randolph, NJ

22d•$19

About The Position

Assure compliance with the requirements of 21CFR Part 211 section 211.192 which states that all drug product production and control records shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Works closely with the Account Managers, Customer Service, Production, Quality Operations and Warehouse to assure all job-related paperwork complies with regulatory and customer requirements. Supports the Quality System Manager and team by supporting key Quality System Programs, including a selection of the following: Document Control, Change Control, Records Control, Internal and External Audits, Food Safety compliance, Annual Product Reviews, Regulatory Filings, and Continuous Improvement initiatives.

Requirements

High school diploma or equivalent required.
4 years plus of similar experience, required.
In-depth knowledge of governing regulations of packaging, labeling, of pharmaceutical.
2-3 years of GDP/GMP experience required.
The ability to work independently, without supervision required.
Ability to organize priorities and workload required.
Ability to work and communicate with cross-functional teams.
Ability to demonstrate critical thinking.

Nice To Haves

Associates Degree or equivalent combination preferred.

Responsibilities

Perform Acceptance Quality Level (AQL) sampling and evaluation as required to assure product quality
Assist in ensuring production area is maintained in a state of inspection
Provides support in the Line Clearance and Cleaning Verification for packaging operations per established Standard Operating Procedures (SOPs) and batch/packaging and labeling records
Conducts real time (in-process) audits and thorough batch record reviews throughout the production process
Supports management with a discrepancy or deviation, and provides support to the investigation team
Provides timely notifications to the customer for incoming quality related issues
Performs periodic audits of finished product for compliance to customer packaging orders
Troubleshoot problem areas and apply problem-solving techniques to their resolution
Monitor quality of incoming and finished product, working towards continuous quality improvement
Assist in the performance of internal assessments and audits necessary to assure compliance
Supports and performs incoming Quality inspections and batch record review regularly
Supports Primary Packaging and Serialization orders
Serves as mentor/trainer to new Quality members
Performs certifications for new Quality and Production members
Assists with Orientation and GDP/Data Integrity training
First responder problem solver with Quality issues
Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions
Provides assistance and answers questions when needed to Support Staff and Production Staff.
Instills a sense of quality through modeled quality behaviors and mindset
Adherence to all Company policies, procedures, cGMPs, and regulatory requirements
Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions
Instills a sense of quality through modeled quality behaviors and mindset
Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed