Quality Assurance Manager in Rensselaer, NY at AMRI

Date Posted: 8/29/2019

Job Snapshot

Job Description

Manager, Quality Assurance in Rensselaer, NY

Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Manager, Quality Assurance, is responsible for providing professional expertise and leadership in the Quality function.  The Manager is responsible, along with the Head of Quality Assurance, for ensuring that all manufactured materials are in accordance with the Company’s quality assurance program and quality/reliability standards to satisfy cGMP regulatory requirements and customer specifications and expectations.

RESPONSIBILITIES

  1. Assist the Head of Quality Assurance with the development, implementation, optimization and strict adherence to a quality assurance program which meets the most up-to-date regulatory requirements and the AMRI global quality directives.  Develop and/or review and/or approve standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials, as assigned. 

  2. Develop and motivate Quality Assurance staff to effectively carry out department functions; provide leadership, guidance and direction of staff consistent with cGMP and company corporate quality objectives. Coach and mentor staff in all aspects of their job performance and career development including training, feedback and disciplinary action. Ensure that the staff has a full understanding of department processes and procedures.

  3. Manage the disposition of all raw materials, intermediates, packaging and factory supplies, and all finished goods for commercial and clinical operations.

  4. Manage the Quality Events Management System for deviations, failure investigations, out of specification/out of trend investigations, calibration out of tolerance events, CAPAs and CAPA effectiveness monitoring.  Ensure that all Quality Events are completed in the time required by company procedure and that all investigations are completed in a thorough manner to appropriately identify root cause and corrective/preventative actions.  Authorize critical deviations and provide guidance and troubleshooting during investigation.

  5. Manage all customer complaints and recalls.  Authorize material returns and destruction, including recommendation of corrective action plans/programs for overall defect reduction

  6. Report serious or repeated failures or unreliability in quality of products to Head of Quality Assurance.

  7. Manage the preparation and approval of master batch records, cleaning batch records, monographs, and test methods.  Review and oversee implementation of change notices and related document change control.

  8. Manage the issuance of production batch records, equipment log sheets, and log books.

  9. Manage the review of all manufacturing and test documentation to assure conformance to quality standards including the review of production and cleaning batch records, shipping records, stability protocols, pest control activities, testing and inspection records, and customer contract specifications. 

  10. Approve master item number data and changes, as well as finished good labels.

  11. Authorize reprocess, rework, disposal or return to vendor decisions.  Approve inventory adjustments.

  12. Participate on cross functional teams and quality global inter-site initiatives representing the site Quality department, as assigned.

  13. Manage and participate in the QA on-call rotation.

  14. Prepare, review reports and other documentation required by regulatory agencies to support the quality assurance function.

  15. Provide support during regulatory inspections and customer audits.  Assist in performing inspection readiness activities and supplier audits.

Job Requirements

Education and/or Experience

•       Minimum Bachelor of Science in Chemistry or a related field

•       Minimum five years’ QA, RA experience in pharmaceuticals or a related cGMP regulated industry

•       Minimum two years supervisory experience or coach/mentor role

•       Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).

•       Knowledge of pharmaceutical processes to be able to make appropriate decisions.

•       Strong attention to detail is required.

•       Strong interpersonal, written and oral communication skills.

•       Excellent communication and collaboration skills and demonstrated ability to work cross functionally across internal stakeholders.


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:  Standard 8

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.

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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.