Quality Assurance Systems Specialist in Albany, NY at AMRI

Date Posted: 11/7/2018

Job Snapshot

Job Description

Quality Assurance Systems Specialist in Albany, NY

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Quality Assurance Systems Specialist is an integral part of the AMRI team, contributing to our success by providing Oversight of Quality Management System (QMS) to ensure compliance with cGMPs, AMRI, Customer and Regulatory standards according to requirements.  Specifically, the QSS main objective will be to maintaining, monitoring and improving quality system elements and support the execution of the Quality Management System (QMS) at the site thru review and approvals of CAPAs, and continual improvement initiatives. This position will focus on the following processes including but not limited to CAPA, Change Controls, Deviations, OOS, OOT, Calibration OOT, Complaints and Quality Risk Management elements of the QMS as well as managing audits. The position may also support document and records management.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture, supplier quality anagement program and training.

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

1.      Oversees and administers SOP, document and records management system, as well as the deviation, change control, complaint handling, training and CAPA systems.  This entails ensuring that the processes, their respective procedures and their use meet current regulatory expectations and industry best practice.

2.      Review and manage System records for assignments and closures.

3.      Act as site Super User for AMRI Document Management Systems (Master Control, Stratas).  The Quality Systems Specialist (QSS) works closely with System Administrators, Users and IT to ensure the system is used as intended.  The QSS is the business subject matter expert in the processes facilitated by the Master Control document management system.

4.      QSS will be the site go to and contact for site Document Management Systems (Master Control, Stratas).

5.      Participates in MasterControl and Stratas projects in the continued improvement of the system and roll out across other sites.  Typical activities may include, leading the development of user requirements, training of users as needed, testing of new functionality, development of SOPs and leading the Master Control and Stratas SME Forum on as needed basis and frequency.

6.      Uses appropriate tools to compile, track, trend, analyze and report key performance indicators and metrics in order to identify areas of non-compliance, best practice and identifying continuous improvement initiatives. 

7.      Prepares information related to the state of the QMS to be used in routine monthly reporting and Quality Council meetings.

8.      Proactively, based on data analysis, recommends to management areas of improvement within the various operations and departments.

  1. Maintains the supplier quality management program, ensuring that vendors and suppliers have been properly qualified/re-qualified prior to their use in GMP activities.
  2. May conducts vendor/supplier audits.  These could be desk audits or physical audits based on procedures and documented risk assessment.
  3. Assists in preparation and participates in internal/external audits and regulatory inspections as needed.
  4. Ability to Author and Revise SOP’s while Maintaining inspection ready procedures, data and records pertaining to the QMS
  5. Ability to develop relationships and coach business users on CAPA system requirements.
  6. Participates in self-development activities to stay current with regulatory expectations and industry best practices in quality management systems.

  1. Complete the Albany Quality Assurance Core Competency in the MasterControl Document management system.

  1. Exhibit safety awareness and safe work practices.

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

  1. Ability to take instruction, work in a team and in an individual capacity.

  1. Ability to develop relationships and coach business users on Quality system requirements.

  1. Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.

  1. Excellent time and project management skills with the ability to manage many diverse tasks simultaneously with a strong attention to detail.

  1. Effectively organize and manage work responsibilities under general guidance.

Job Requirements

QUALIFICATIONS

 

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

  • BS preferably in Chemistry or a related field.
  • At least Four (4) years industrial GMP experience in an FDA-regulated pharmaceutical environment.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and working knowledge of Microsoft Project and SharePoint is a plus.
  • Basic quality tools (i.e. pareto charts, histograms, cause-and-effect)
  • Experience in QMS platforms a plus (i.e. Documentum, TrackWise, MasterControl)



Language/Communication Skills

Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations with ability to effectively interact with a broad spectrum of audiences.  Strong written and verbal communication and presentation skills.  

Mathematical Skills

Ability to apply the mathematical concepts from algebra and geometry.

Reasoning Ability

Ability to solve problems with a variety of variables using past experience. Ability to interpret instructions furnished in written, oral, diagram, or schedule form.

All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.


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.