Quality Systems Manager West Caldwell, NJ Posted: 5/23/2023
Job Description
Job ID#:
175592
Job Category:
IT/Technical
Position Type:
Associate - W2
Duration:
DH
We have an outstanding career opportunity for a Quality Systems Manager to join a leading Company located in the West Caldwell, NJ surrounding area.
The Quality Systems Manager will work within the Quality team and play a vital role in the creation and evaluation of all company Quality systems. The Key Objective of the Quality Systems Manager is to ensure that all company Production Quality systems meet and are delivering against all regulatory requirements. They will provide support for product assurance from design effort to initial product qualification followed by the first phase of production. They will interact with production and engineering personnel to set up production test requirements and new product qualifications.
Responsibilities:
This position supports the daily QA departmental operations and assists the Director of Quality in ensuring compliance in all areas
The Quality Assurance Manager is responsible for supporting the Quality System in conjunction with client needs and requirements to ensure compliance with FDA CFR 110, 111, 117, 210 & 211 and customer-specific requirements
Provide Quality support for all new client management and managing all product launches and new product SKU's as well as all special projects
Train all required personnel to ensure a successful launch and production run
Assists in evaluating all new client and product prospects to determine specific registration, certification, and license requirements; this will be completed alongside the Director and/or QA Specialist
Must attend all new product meetings to be aware of all documentation and specific quality requirements; including but not limited to, Master Batch Record requirements, and revisions, packaging and shipping requirements, sampling requirements, validation requirements, or registration requirements
Develop and oversee all Stabilities and Validation activities; IQ/OQ/PQs for equipment, cleaning, or other special project protocols
Oversee the calibration process
Update and create Standard Operating for Quality Assurance-related activities
Effectively monitor and enforce compliance with the company's SOPs and cGMPs
Oversee the HACCP (Hazard Analysis and Critical Control Points) Program
Manage activities related to external labs and consultants
Review and approve lab reports and ensure consistency with MP standards
Responsible for environmental program cleaning validation and pathogen detection
Perform Risk Assessment for new products and Annual Review for Environmental Monitoring Programs, Cleaning Validation, and Pathogen Detection Programs
Oversee the CAPA process with emphasis on the timely completion of tasks
Deliver and update reports related to KPIs
Oversee the Pest Control Programs, providing monthly updates of any inconsistencies
Provide administrative/technical support to the Director of Quality and the Quality Team
Assist with FDA and other regulatory agency inspections
Assist the QA Specialist in drafting and/or writing change controls, complaints, deviation, and investigation reports
Maintain an organized workplace
Perform other related duties as assigned
Basic Hiring Criteria:
Bachelors' degree in a scientific field is strongly preferred
Minimum 5 years of experience in a pharmaceutical and/or nutritional supplement industry
Minimum 5 years in pharmaceuticals
Minimum 2 years of experience in management or supervising a team
Desired Qualifications:
Knowledge of FDA CFR 210-211 cGMP regulations and guidelines and QA best practices
Experience working with Contract Packaging and/or Manufacturing Organizations is a must
Validation experience is strongly preferred
Experience with new product launches is strongly preferred
Excellent technical writing skills are a must
Demonstrated experience with Quality Systems
Must be self-motivated and able to work independently but maintain a team-focused attitude
Excellent attention to detail and follow-through and organizational skills
Ability to advocate a quality environment
Excellent verbal, written, and interpersonal communication skills
Advanced Excel skills
Ability to motivate and build strong relationships with internal team members as well as with clients, when required
Proactive thinker
Ability to identify potential issues beforehand and raise them to management with possible solutions
Verbal interactive communication skills
Job Requirements
Minimum Security Clearance:
No Clearance
TAD PGS, Inc. is a Global Fortune 500 company with worldwide revenue of over $27 billion and more than 50 years of government contracting experience. We specialize in supporting U.S. Government Agencies and their prime vendors by delivering a full range of recruitment and workforce solutions. As part of the Adecco family, we have access to over 2.5 million active candidates supporting hundreds of locations across North America. On any given day, we have more than 70,000 professionals working at client sites across the United States.