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Quality Assurance Manager

  • Ref: 310036
  • Type: Direct Hire
  • Location: South Plainfield, NJ
  • Industry: Vitamins Nutritionals / Other Health-Related Products
  • Job Level: Manager
  • Pay: Negotiable

Opportunity Description

Quality Assurance Manager is responsible for establishing and maintaining protocols and procedures to ensure compliance to FDA cGMPs for the manufacturing, handling, storage, distribution of dietary supplements

Company Information

Vitamins, Dietary Supplements

Job Duties

  • Develop, implement and maintain processes in a proactive manner to reflect the company’s core values.
  • Daily implementation of inspections are to be conducted with these indicators (core values) in mind so that improvement can be attained, resulting in better quality and high efficiency.
  • Communicate consistently and with a sense of urgency with different departments within the plant, to include but not limited to, human resources, maintenance, shipping / receiving, maintenance, warehousing, and production operations.
  • Will be responsible for all interactions with government/regulatory agencies, and vendor (3rd party) audits.
  • Will interact with other entities outside the company structure: Examples include - customer visits, inspections, and audits as well as third party audits representing customers, pest control service providers, and testing equipment vendor’s / service providers.
  • Manage the IQ, OQ, PQ of the equipment
  • Manage quality management systems for manufacturing plant, packaging and warehousing and administrative support functions, including document control, site audits, and corrective & preventive action systems.
  • Manage Sanitation Program for the Site.
  • Oversee all activities pertaining to sanitation to ensure compliance to all Sanitation Standard Operating Procedures and cleanliness standards while executing timely start-up of the plant each production day.
  • Develops and maintains all Sanitation Standard Operating Procedures and the Master Sanitation Schedule.
  • Works with purchasing and chemical provider to have the proper types and amount of chemicals and cleaning supplies on hand to ensure the ability to follow cleaning procedures.
  • Monitor pest control procedures in the facility and ensures a pest/rodent free facility. Discusses all pest control problems with the designated pest control company.
  • Manage customer complaint tracking and trend reporting.
  • Manage Internal Audit and CAPA database for verification and effectiveness.
  • Manage Change control request and deviations.
  • Establish material traceability, and suspect material quarantine procedures.
  • Establish and manage vendor qualification program, including source inspection & audits, supplier rating, first article, and incoming inspection for inbound material, according to company quality standards.
  • Oversee the program management, materials management, and outsourcing departments to ensure that QA standards are established as requirements during product planning.
  • Establish product rework standards and disposition controls by developing a material review board (MRB) approval process.
  • Oversee the managing and monitoring of environmental samples of building and facilities including utilities involved in the GMP environment
  • Draft, review and maintain internal and ex

Education

BS degree in a relevant technical curriculum.

Experience & Skills Required

  • Quality management: 3 years (Required)
  • 5+ years of direct experience in a GMP or QSR industry.
  • 3+ years of supervisory/managerial role in GMP Environment.
  • Excellent written and verbal communication skills
  • Strong interpersonal skills and management ability
  • Detail-oriented
  • Problem solving skills
  • Able to use Microsoft Office very proficiently
  • Must work on “process level” and “organizational level” with cross functional understanding
  • Perform a high level of review for all team members.
  • This position requires a highly motivated individual with exceptional leadership and communication skills to help develop and lead culture of quality among the company’s employees, departmental leaders, and manufacturers. Hold team members accountable to ensure that actions and behaviors
  • To communicate and report to manufacturing and management and do corrective actions when appropriate, deviations and defects when outside the specifications as directed in the Master Manufacturing record with a sense of urgency in real time.
  • Ability to utilize current enterprise systems comprehensively and reduce dependency on static spreadsheets

Certifications

ISO 9001: 1 year (Preferred)