Quality Assurance Specialist , 3rd Shift in Burlington, MA at AMRI

Date Posted: 11/3/2018

Job Snapshot

Job Description

About the Position

The Quality Assurance Specialist II is responsible for maintaining Quality databases and providing on-the-floor QA presence and oversight to the manufacturing operation.  The QA Specialist’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMP’s and internal procedures/policies is maintained, b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.

Position Responsibilities
Other duties may be assigned

  • 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 in regulatory and client audits.

Job Requirements

Position 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: Bachelor’s degree in life science field required

Relevant Work Experience:  4-6 years’ experience of pharmaceutical/biotechnology or medical device industry experience; Minimum of 2 years’ experience in Quality Assurance

Knowledge, Skills & Abilities:

•         Excellent written and verbal presentation and communication skills

•         Strong facilitation skills

•         Strong problem solving skills, with the ability to resolve conflict

•         Ability to effectively present information to management and/or peers

•         Comfortable working independently in combination with individuals in other departments across the organization

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear.  The employee frequently is required to reach with hands and arms.  The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work Environment
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).  The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required).  The noise level in the work environment is usually moderate. 

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.




Shift:  Third 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.