Associate Director, Quality Control - NY
Company: Curia
Location: Amityville
Posted on: March 20, 2023
Job Description:
The Associate Director of Quality Control also ensures
compliance of the analytical laboratories and operations to the
most current data integrity requirements, drives continuous
improvement activities and implementation of industry best
practices in the QC laboratories to maximize efficiency while
maintaining a high compliance level. The Associate Director will
interact with Curia internal and external customers.
To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
functions.
Supervisory responsibilities
This position does have supervisory responsibilities.
Essential job duties
- Direct the Quality Control department. This includes, but is
not limited to, scheduling and overseeing testing and operations of
quality control team(s) responsible for samples and incoming,
in-process and final products testing, coaching and mentoring QC
analysts, supporting troubleshooting activities and
investigations
- Ensure QC laboratories, and operations are cGMP compliant. This
include but is not limited to overseeing of analytical equipment
qualification, maintenance and calibration programs, ensuring that
QC procedures, practices and analytical methods are in compliance
with the applicable compendial, regulatory and customer
requirements and that QC investigations and thoroughly
conducted
- Ensure that the QC functions are completed in accordance with
the Company and governmental standards of safety and quality, and
that all experimental documentation is complete and timely
- Define the need of the laboratory in terms of equipment and
people. Responsible for preparing QC budget of expenses and
Capex
- Partner with site stakeholders to achieve and maintain
operational excellence, site quality compliance and a strong
quality culture site-wide while maximizing efficiency of the QC
laboratory to achieve the site business goals
- Collect, monitor and report quality control key performance
indicators identifying and leading opportunity for improvements to
achieve and maintain high quality, productivity and efficiency of
the QC department
- Support Curia global quality and continuous improvements
initiatives. Recommend and implement methods and techniques to
increase the quality of products and/or service
- Oversee pharmaceutical analysis to support drug product
manufacturing
- Mentor, coaches and provide in continuing training to QC
personnel to increase the level of technical skills and compliance
in the department
Education, experience, certification and licensures Required
Bachelor's/Master's degree in Chemistry, Analytical Chemistry or
related field Minimum 12-15 years' experience in the pharmaceutical
industry in drug substance or drug product manufacturing, including
5 years' experience in Quality Control Minimum 10 -15 years'
experience in a professional management role Preferred Advanced
degree in Chemistry, Analytical Chemistry or related field
Knowledge, skills and abilities
- Combined ability to mentor and coach individuals and ability to
motivate teams to reach a common goal
- Strong knowledge of cGMP regulations applicable to API
manufacturers, including FDA regulations
- Strong knowledge of analytical techniques, such as HPLC, GC,
PSD, and wet chemistry with proven ability to solve complex
problems
- Strategic thinking
- Strong communication skills
- Ability to read, analyze, and interpret general business
periodicals, professional journals, technical procedures, or
governmental regulations
- Ability to write reports, business correspondence, and
procedure manuals
- Ability to effectively present information and respond to
questions from groups of managers, clients, customers, and the
general public
- Ability to calculate figures and amounts such as discounts,
interest, commissions, proportions, percentages, area,
circumference, and volume
- Ability to apply concepts of basic algebra and
geometry
- Ability to solve practical problems and deal with a variety of
concrete variables in situations where only limited standardization
exists
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form
All interested applicants must apply online. Curia is an Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability.
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Keywords: Curia, New Haven , Associate Director, Quality Control - NY, Executive , Amityville, Connecticut
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