Quality Assurance Specialist II in Burlington, MA at AMRI

Date Posted: 5/7/2020

Job Snapshot

Job Description

Description

AMRIprovides global contract research and manufacturing services to thepharmaceutical and biotechnology industries.

TheQuality Assurance Specialist II is responsible for maintaining Qualitydatabases and providing on-the-floor QA presence and oversight to the manufacturingoperation. The QA Specialist’s role will include identifying compliance risksin the operation prior to and during execution, avoiding deviation wheneverpossible as well as managing immediate corrective action such that a) adherenceto cGMP’s and internal procedures/policies is maintained, b) appropriateimmediate corrective action is implemented and effectively documented in orderto provide traceability and substantiation of any claims to be made in theinvestigation. This position primarily works in the cGMP production areas tomanage adherence to the quality system and to initiate and assist in theinitiation and resolution of deviations.

Joinour talented workforce, where a commitment to excellence and a customer focusedattitude is everything. We pursue excellence because our work has the power toimprove patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities

  • Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP’s and AMRI’s quality system to ensure real-time compliance
  • Represent AMRI Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented
  • Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications
  • Monitor Operations personnel for adherence to SOP’s. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
  • Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records
  • Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation
  • Authors or revises SOPs
  • Performs manufacturing area and labeling clearances as well as inspection of material
  • Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports
  • Assists in performing investigations
  • Performs internal audits and weekly walkthroughs
  • External audits for Supplier qualification
  • With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
  • Assists in developing and delivering training
  • Assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
  • Develops and/or maintains Quality System metrics for Management Review
  • Provides on the floor support to manufacturing operations
  • Perform QA visual inspection activities associated with clinical and commercial drug product
  • Participate inregulatory and client audits

Qualifications

• Bachelor’sDegree in Life Science field required

• 4 years of experience in Pharmaceutical/Biotechnology or Medical Device industry;Minimum of 2 years of experience in Quality Assurance

• Excellentwritten and verbal presentation and communication skills

• Strongfacilitation skills

• Strongproblem solving skills, with the ability to resolve conflict

• Abilityto effectively present information to management and/or peers

• Comfortableworking independently in combination with individuals in other departmentsacross the organization

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

Job: Quality
Primary Location: US-MA-Burlington
Other Locations:
Organization: AMRI Burlington
Schedule: Full-time
Job Posting: May 10, 2020, 12:53:02 PM
Shift Type: First Shift

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.