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Quality Assurance Manager

Company: American Pacific Corporation
Location: Rancho Cordova
Posted on: June 6, 2021

Job Description:

AMPAC Fine Chemicals (AFC), an SK pharmteco company, is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California, Texas, and Virginia specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities.

We are looking for a QA Manager to join our team in Rancho Cordova, CA (greater Sacramento Area, CA) area.

The Quality Assurance Manager impacts a wide range of responsibilities from operation and project management needs to customer support and management. The manager will oversee a group of QA professional from all levels of experience and will be the primary point of contact for the management of a set of projects. The manager will use AFC's Quality Systems (managed within Master Control, an electronic document management system) to ensure timely progressions and accurate completion of documents. This position includes management of a team of QA specialists and analysts to support production lines and customer expectations.

Key Responsibilities:

  • Ensuring that adequate QA resources are provided for the cross functional internal team meetings and Customer teleconferences.
  • Responsible to manage the quality aspects of start-up of production lines through release of final products Manager will align customer needs and AFC's completion projections for the lots manufactured.
  • Taking an active role providing, as appropriate, guidance within the approved systems and procedures as it related to GMP production and release of products, some of this guidance may be required outside of the typical working schedule (off shift).
  • Taking an active role in planning, and when needed, execution of action items related to support of production and product release, including document control and production record review activities.
  • Managing the release of products to support subsequent production and release of product to customer within the approved systems and procedures. Managing change controls in support of production and release activities.
  • Review and/or conduct of investigations for deviations in production and testing.
  • Manager will have review input for Quality Technical Agreements (QTA). Manager will assure his/her team has access to the QTA and follows closely the approved agreements.
  • Ensuring process validation and qualification requirements are established in approved protocols and results of the validation and qualifications are accurately presented in approved reports.
  • Responsible for managing facility audits of the respective manufacturing facilities of responsibility at the start of each campaign and periodically while long running campaigns are active.
  • The manager is expected to monitor progress of the quality systems and work with system coordinators to drive KPI improvement.
  • QA manager has the overall responsibility to manage all quality aspects related to the product(s) assigned.
  • Direct management of 2-5 QA professionals in support of GMP manufacturing.
  • Work with other functional management to proactively look for continuous improvement for the quality organization and to assist in the betterment of manufacturing operations.
  • Involvement in customer and regulatory audits as the QA representative subject matter expert for product(s) of responsibility.
  • Closely monitor KPI (key performance indicators) for products under your responsibility and create tools, training, changes, procedure, etc. to create an environment of continuous improvement.

Education

  • Bachelors degree in an appropriate science.

Experience

  • 5-10 years of related technical experience or equivalent combination of education and experience.

Skills

  • Strong attention to detail.
  • Ability to work in a fast paced, team-oriented environment.
  • Ability to act with a sense of urgency, while maintaining accuracy and data integrity.
  • Strong team building, decision-making and people management skills.

Keywords: American Pacific Corporation, Rancho Cordova , Quality Assurance Manager, Other , Rancho Cordova, California

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