MQA Analyst in Albuquerque, NM at AMRI

Date Posted: 11/3/2018

Job Snapshot

Job Description



Manufacturing Quality Assurance Analyst

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

Summary: The MQA Analyst will assist in management of the daily activities of the Business Unit, but will report independently to the Manager of MQA. The MQA Analyst will be responsible for providing direct Quality Assurance support to the Manufacturing shop floor. The MQA Analyst, with direct supervisory guidance, will be responsible for a diverse and challenging set of activities, all of which are related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international GMP regulations and guidance's.
Responsibilities:
  • Performing line clearances and line monitoring
  • Having a basic knowledge of problem solving techniques and demonstrating the ability to troubleshoot with limited supervision
  • Verbally express ideas, facts and proposals that are clear, logical, and concise manner
  • Recognizing atypical data and reporting it to the appropriate supervisor or designee
  • Able to work effectively with other departments, coworkers, and QA teams Being proficient at technically reviewing/auditing shop floor records and reports such as logbooks and other types of documentation for completeness and accuracy
  • Assisting MQA Specialists or MQA Sr. Manager to identify technical problems and provide guidance and support to real time shop floor quality issues up to and including: making real time product impact assessments, and go no go decisions
  • Participating in quality systems implementation and maintenance efforts to ensure alignment with business process needs and user requirements
  • Awareness of changes impacting internal SOPs, recommending modifications for SOPs and author, review and edit documents, protocols, and problem reports
  • Working with the Quality Compliance and QAPS group to evaluate deviations related to production batches, the laboratories, or the facility
  • Working with the QA Product Specialists to support customer issues, investigations, corrective actions and change controls QA operates 24 hours a day, 5 days a week for production support
  • Responsible for performing and providing QA leadership for the Business Units. 
  • Responsible for all quality aspects of production operations on assigned shifts, including working directly with the QA Product Sr. Analyst or MQA specialist as needed to address customer related quality concerns or issues.
  • As an entry-level position, under direct supervision, this position requires limited independent judgment. The work is routine and well defined. MQA Analysts will be required to discuss actions to be taken with the supervisor or designee before resolving problems.
  • Represent MQA leadership on shift to support production operations, including real-time review. 
  • Provide technical expertise and internal technical consulting within the Albuquerque facility.
  • Provide information to customers to resolve quality related issues related to customer’s batches.
  • Review and approve regulated documents as needed for product disposition.
  • Conduct, review, and approve process and product investigations as needed for atypical events.
  • Provide training on cGMPs to the QA group and Production.

Job Requirements

Other Skills and Abilities:                  

  • Excellent Communication skills, both verbal and written. Ability to organize time in order to successfully manage multiple projects and priorities.
  • Ability to read, understand, interpret and implement technical writing and instructions.
  • Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals.
  • Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
  • Willing to be on call to answer questions from production 24hours/5 days a week.
  • Root cause analysis trouble-shooting experience.
  • Knowledge of aseptic processing technique.
  • Ability to train and advise QA professionals and production personnel.
  • Ability to assess and review all regulated product-specific documentation.

Education and Experience:

  • BS or BA in Science, Chemistry or Biology, or 4 years experience in a manufacturing environment;
  • A minimum of 2 year's experience in an aseptic manufacturing environment preferred.

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.

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.