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Associate Director, Quality Control

3 months ago

Canandaigua, New York, United States curiate Full time
Job Description

Associate Director of Quality Control in Rensselaer, NY

The Associate Director of Quality Control (QC) is responsible for leading the Quality Control unit at the site and for providing analytical technical guidance to the various site functions. This position's responsibilities include but are not limited to overseeing total quality control activities, such as testing and releases of raw materials, intermediates and APIs and/or drug product manufacturing, support to production, proper life-cycle of analytical methods (i.e. validation, transfer, review, approval, changes), OOS/OOT investigations, stability programs and compliance to the applicable compendial, regulatory and customer requirements.

The Associate Director 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.

We proudly offer:
  • Generous benefit options (eligible first day of employment)
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401k program
  • Learning platform
  • And more
Supervisory responsibilities

This position does have supervisory responsibilities.

Essential job duties
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. Support Curia global quality and continuous improvements initiatives. Recommend and implement methods and techniques to increase the quality of products and/or service
  7. Oversee pharmaceutical analysis to support drug product manufacturing
  8. 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 degree in Chemistry, Analytical Chemistry or related field
  • Minimum 10 years' experience in the pharmaceutical industry in drug substance or drug product manufacturing, including 5 years' experience in Quality Control
  • Minimum 8 years' experience in a professional management role
Preferred
  • Advanced degree in Chemistry, Analytical Chemistry or related field
Knowledge, skills and abilities
  1. Combined ability to mentor and coach individuals and ability to motivate teams to reach a common goal
  2. Strong knowledge of cGMP regulations applicable to API manufacturers, including FDA regulations
  3. Strong knowledge of analytical techniques, such as HPLC, GC, PSD, and wet chemistry with proven ability to solve complex problems
  4. Strategic thinking
  5. Strong communication skills
  6. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  7. Ability to write reports, business correspondence, and procedure manuals
  8. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  9. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
  10. Ability to apply concepts of basic algebra and geometry
  11. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  12. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Pay Range:

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a email address. 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. Curia is an E-Verify employer.

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