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Manufacturing Quality Assurance Specialist - ABQ

Company: Curia
Location: Amityville
Posted on: March 20, 2023

Job Description:


The Manufacturing Quality Assurance (MQA) Specialist will be an essential part of the Business Unit's management team. The MQA Specialist will assist in the management of the daily activities of the Business Unit but will report independently to the Manager of MQA. The MQA Specialist will be responsible for providing direct Quality Assurance support to the manufacturing shop floor. The MQA Specialist, 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 guidances.

Essential Duties and 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 Analysts or MQA Senior 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 authors, reviewing and editing 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. The selected candidate will be required to support the graveyard shifts (B&D). Other duties as assigned.

    Supervisory Responsibilities:

    This position will supervise the other graveyard MQA Analysts.

    Education and/or Experience:

    Bachelor's degree (B. S.), m inimum of four (4) years experience, preferably in an aseptic manufacturing environment.

    Language Skills:

    Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly. Ability to speak effectively.

    Mathematical Skills:

    Ability to apply basic math concepts.

    Reasoning Ability:

    Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

    Computer Skills:

    Proficient in the use of MS Word, Excel, Outlook, and Access, as this individual will perform work within these systems on a routine basis.

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

    Other Qualifications:

    Must pass a background check.

    Must pass a drug screen.

    Physical Demands:

    While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use their hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

    Work Environment:

    While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

    All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

    Note This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.

Keywords: Curia, New Haven , Manufacturing Quality Assurance Specialist - ABQ, Other , Amityville, Connecticut

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