Associate Director, Quality Assurance
Akorn 2

Somerset, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


SUMMARY:
Responsible for cGMP compliance ensuring all FDA regulations, internal procedures and other regulatory requirements are adhered to as it relates to production support and documentation. Ensure all commercial products manufactured, processed, packed or held at the site meet requirements for product identity, strength, quality, and purity, including products for regulatory submission. In addition, manage, direct, and mentor QA staff.

ESSENTIAL FUNCTIONS:

  • Develop, implement, sustain, and improve QA production support to meet FDA regulations, ICH, internal procedures and other regulatory requirements, while maintaining customer satisfaction.
  • Ensure Quality Assurance Production Support include written procedures to ensure QA has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging/labeling materials, and drug products. This includes review and approval of all records impacting the identity, strength, quality and purity of materials per 21 CFR parts 210 and 211.
  • Oversight of the release of raw materials, packaging components, and finished product.
  • Evaluate personnel requirements of the quality assurance, as it relates specifically to QA production support (room clearances, batch release, material release, etc.).
  • Oversee QA documentation (issuance of batch records, SOPs, change controls, etc).
  • Support, as necessary, product release and cross-train with quality systems counterpart.
  • Administer the site quality assurance program as delegated by the Executive Director - QA/QC.
  • Assure consistency of purchased components by vendor certification, establishment of effective acceptance criteria, and product monitoring.
  • Administer and support program for annual product reviews for all commercial products.
  • Act as a delegate/assigned designee to perform functions on behalf of the Executive Director, Quality as it relates to Quality Assurance production support and documentation.
  • Responsible for the overall direction, coordination and evaluation of this unit. Directly supervises Manager for Documentation, QA Supervisors, and QA Batch Release Supervisor.


Qualifications
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed 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.

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
  • Excellent interpersonal, oral, and written communication skills.
  • Requires exceptional attention to detail with the ability to focus on current assignments.
  • Must have accomplished skills in computer-assisted documentation systems.
  • Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
  • Must have a team work attitude.
  • Will interact with all functional departments within the company including hourly, professional and management personnel.
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
EDUCATION AND EXPERIENCE:
  • Bachelor’s Degree (BS or BA) in a science related filed (i.e. math, chemistry, biology)
  • Ten years in the pharmaceutical industry with 5 years of related managerial experience.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
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.

This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and mental requirements include:
  • Ability to hear accurately the spoken word with moderate office noise or plant noise
  • Ability to apply deductive reasoning and understand complicated issues
  • Ability to receive instructions and follow work rules and company policies
  • Ability to follow safety and security practices
  • Ability to meet deadlines and effectively deal with office stress
  • Ability to accurately communicate ideas, facts and technical information


Company Overview
Who we are?

Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients’ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website atwww.Akorn.com

Why choose us?

Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!

What do we offer?
  • Competitive pay
  • Growth and development opportunities
  • Tuition Reimbursement
  • 3 weeks PTO + Personal Days
  • 9 company holidays
  • 401K match
  • Medical, Dental and Vision Benefit Options
  • 100% Paid Maternity Leave
  • Fast paced, family-oriented work environment
  • Wellness Program
  • Inclusive and diverse culture
  • Adoption Assistance
  • Flexible Spending Accounts


EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


This job has expired.

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