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Director of QA

Apex Systems Amityville Full-Time
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Director of QA

JOB SUMMARY

The Director of Quality Assurance aims to ensure that the company meets both external and internal requirements, regarding quality.  This position develops and implements the activities required to meet quality standards and is responsible for ensuring that FDA standards and company specific requirements are met and integrated into a Total Quality Management (TQM) Program which executes Quality By Design (QBD).  The Director of Quality Assurance also sets and maintains standards for quality measurement, acceptance and rejection of finished goods, bulk product, packaging components and raw materials.  They will also interface directly with FDA under the guidance of the management team.

Responsibilities

  • Oversee/Manage the QA department
  • Administer/oversee Internal Audits.
  • Administer/oversee External Manufacturer Audit Surveys.
  • Administer/oversee data collection from production, labeling and field inquiries regarding quality
  • Advise and implement on matters related to Good Manufacturing Practices.
  • Chair or advise Technical Advisory Committee on regulatory matters.
  • Oversee the review of labels and ancillary printed materials for regulatory compliance.
  • Oversee the review of reports related to Annual Product Review.
  • Review reports related to customer complaints
  • Manage day-to-day operations of quality control department.
  • Oversee the GMP review for products related to Adverse Product Reactions.
  • Oversee the preparation of customer driven Deviation Reports.
  • Oversee internal Deviation Reports and related investigation.
  • Participate/Assist as required in Out of Specifications Investigations and Deviations initiated by other departments.
  • Write Standard Operating Procedures (SOP).
  • Oversee annual review of deviation reports
  • Oversee annual review of non-conformance reports
  • Oversee SOP training.
  • Assure compliance with customer SOPs.
  • Quality liaison for contract accounts. 
  • Promote quality achievement and performance improvement throughout the organization (TQM).
  • Approving standards and establishing clearly defined quality methods for staff to apply.
  • Setting up and maintaining organized controls and documentation procedures
  • Supervising quality assurance personnel in carrying out tests and checks.
  • Develop clear understanding of various processes involved in all aspects of the production cycle to ensure proper quality measures are employed.
  • Oversee Non-Conformance reports
  • Communicates with all departments to ensure the QA process is followed.
  • Must stay current on FDA standards that pertain to skin care products.

Requirements

  • 10+  years of supervisor/management experience in OTC pharmaceutical and//or pharmaceutical cosmetics
  • Prior experience with topical products a plus
  • Experience working directly with the FDA on audits
  • BS degree in chemistry/biology

FOR IMMEDIATE CONSIDERATION Please e-mail your resume to Marshena Moncrieffe at Email blocked - click to apply and contact our office at Phone number blocked - click to apply regarding the Director of QA Position

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178

 

Recommended skills

Product Quality Assurance
Good Manufacturing Practices
Packaging And Labeling
Quality Assurance
Auditing
Documentation
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WHAT WE DO:

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.

OUR CREDENTIALS: 

Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.

SUPPORTING OUR CONTRACT EMPLOYEES:

We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.

WHO OUR CUSTOMERS ARE: 

We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities. 

WHERE WE ARE: 

Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.

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