Quality Assurance Manager
Company: American Pacific Corporation
Location: Rancho Cordova
Posted on: June 6, 2021
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
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.
- Ensuring that adequate QA resources are provided for the cross
functional internal team meetings and Customer
- 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
- 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
- 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
- The manager is expected to monitor progress of the quality
systems and work with system coordinators to drive KPI
- 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
- 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
- Closely monitor KPI (key performance indicators) for products
under your responsibility and create tools, training, changes,
procedure, etc. to create an environment of continuous
- Bachelors degree in an appropriate science.
- 5-10 years of related technical experience or equivalent
combination of education and experience.
- Strong attention to detail.
- Ability to work in a fast paced, team-oriented
- Ability to act with a sense of urgency, while maintaining
accuracy and data integrity.
- Strong team building, decision-making and people management
Keywords: American Pacific Corporation, Rancho Cordova , Quality Assurance Manager, Other , Rancho Cordova, California
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