Quality Assurance Manager

Employer
Norac Pharma
Location
91702, Azusa
Posted
Aug 10, 2018
Required Education
Bachelors Degree
Position Type
Full time

Norac Pharma is recruiting for qualified Quality Assurance Manager Candidates for our Quality Assurance Department.

Norac Pharma is a premier Contract Manufacturing Organization for Active Pharmaceutical Ingredients. We are located in Azusa CA, approximately 12 miles east of Pasadena near the 210 and 605 freeway junction. We are a privately held corporation and have been in business since 1957.

For more information, please visit our website: http://www.noracpharma.com/

JOB DESCRIPTION

JOB TITLE:            Quality Assurance Manager

DEPARTMENT:      Quality Assurance

Description:

  • The Quality Assurance Manager will oversee and manage the operations and systems of the Quality Assurance Department in support of the manufacture, testing and release of finished Active Pharmaceutical Ingredients.

Responsibilities:

  • To ensure that all cGMP requirements are being met by all departments engaged in the development, manufacture, processing, packing, analysis, holding, or distribution of product.
  • Provide continuous and proactive QA oversight.
  • Develop any needed procedures for the Quality Assurance function.
  • Manage the Norac Pharma Document Control and Quality Systems function.
  • Administer the quality systems (e.g., change control, deviation system, internal audit program, supplier qualification program, training program, customer complaint program, etc.).
  • Ensuring that the employees within their respective section(s) have the education, training, and experience, or any combination thereof, to perform assigned functions.
  • Ensuring that the employees within their respective section(s) comply with the current Good Manufacturing Practices.
  • Host external audits by clients and regulatory agencies.

Job Duties

  • Audit and review of raw materials, intermediates, final product analytical reports, and batch records.
  • Approval/rejection of labels, intermediates and finished product.
  • Review and approve any training curricula.
  • Inspection, verification and approval of all labeling and artwork.
  • Evaluate and approve investigations, and perform QA Assessments for quality systems (e.g., deviation system, OOS system, customer complaints, etc.).
  • The hiring and training of the Quality Assurance personnel.
  • Develop and provide GMP and Quality Systems training.
  • Interact with all Regulatory Agencies during the course of audits and/or other relevant interactions.
  • Schedule external client audits and coordinate internal resources necessary for the audit.
  • Perform Annual Product Reviews.
  • Perform internal and external audits as required.
  • Review and approval of documents such as SOPs, analytical methods, master batch records, specifications, and validation documentation.
  • Write and revise documentation, when appropriate.
  • Perform trending of product data and quality systems.
  • Supervise assigned Quality Assurance personnel.

Education / Experience / Personal Requirements:

  • Degree in Science, preferably in Chemistry or related field.
  • Minimum five years experience in a Quality Assurance position.
  • Good interpersonal and leadership skills.
  • Detail oriented with critical thinking skills.
  • Ability to operate in a decentralized environment.
  • Ability to manage multiple tasks and prioritize work.
  • Self-motivated with strong organizational and time management skills.
  • Proficient in Microsoft Office applications (advanced knowledge of MS Word and Excel is preferred).
  • Prior experience in MasterControl or electronic document management system a plus.