Quality Assurance Specialist in Albany, NY at AMRI

Date Posted: 10/25/2018

Job Snapshot

Job Description

SUMMARY OF FUNCTIONS

Performs activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, Company and customer quality standards as well as external regulatory requirements. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

§  Perform activities associated with disposition of raw materials and product (e.g. labeling, inspection, documentation review, Release etc.). Activities may be on the production floor or at a desk.

§  Review and approve master and production batch records.

§  Review, edit, or approve controlled documents including standard operating procedures.

§  Disposition final intermediates and APIs (includes review of all associated documentation and application of release labels).

§  Review and approve manufacturing and analytical deviations, out of specification investigations and material non-conformances (i.e Quality Events).  Compile data, prepare and review trends.  Identify areas of concern and communicate to management.

§  Assist in resolving quality issues/concerns and investigation with Analytical and Manufacturing personnel.

§  Review and approve change control documents. Also, any associate Protocol or Validation documents as applicable.

§  Review and approve material release specifications and Certificates of Analysis.

§  Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, Non-conformance etc., including active participation in investigation, evaluation, and problem resolution. Identify areas for improvement to promote continuous improvement of processes and systems.

  • Train and/or mentor junior employees, including providing insights and training on processes and procedures;
  • Collaborate with Analytical to assure required testing is performed as applicable.
  • Maintain inspection ready procedures and participate in internal and customer audits and inspections.
  • Work proactively on a daily basis to ensure schedules are maintained and material is readily available.
  • Identify continuous improvement efforts, including cost/expense control while maintaining GMP compliance.
  • Build quality into all aspect of the material release process by maintaining compliance to all quality requirements
  • Recommend and implement methods to increase the quality of products and/or service.

  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.

  • Participate in self-development activities and training of others.

  • Complete the Albany Quality Assurance Core Competency in the Learning Management System.

  • Exhibit safety awareness and safe work practices.

  • Perform other related duties as may be reasonably assigned in the course of business.

  • Ability to handle, manage multiple assignments /tasks and changing priorities while still meeting deadlines.

  • Ability to learn and utilize computerized systems for daily performance of tasks.

*Level will be determined based on skills and related experience.*

Job Requirements

 

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.

 

Education and/or Experience

v  BS preferably in Chemistry or a related field.

v  QA Specialist - Requires BS/BA in scientific discipline or related field and minimum 2 years industrial GMP experience in an FDA-regulated pharmaceutical environment. Relevant experience may be substituted for education requirement.

v  Senior QA Specialist - Requires BS/BA in scientific discipline or related field and minimum 5 years relevant industrial GMP experience in an FDA-regulated pharmaceutical environment. Relevant experience may be substituted for education requirement.



Language/Communication Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Strong written communication skills including the ability to independently write complex reports, business correspondence, and procedures.    

Mathematical Skills

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.

Reasoning Ability

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.


Shift:  

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.