Specialist Iii, QA Ops

Thermo Fisher Scientific Inc. Cambridge , MA 02138

Posted 2 months ago

Job Description:

Position Description/Summary:

The Quality Assurance Specialist will be the primary point of contact for the customer on all matters related Quality Assurance Operations. This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with Brammer Bio directives and procedures, customer requirements, and regulatory standards.

Essential Responsibilities:

  • Demonstrate an ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

  • Acting with integrity and treating people with respect and courtesy.

  • Constantly striving to make Brammer Bio a great place to work, and a company respected for the quality of its people and products.

  • This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's. The responsibilities include but are not limited to:

Operations Responsibilities:

  • Perform record issuance and record review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA.

  • Conduct review of manufacturing processes to ensure compliance.

  • Conduct review of testing results in support of release of intermediates.

  • Provide compliance guidance to other support teams.

Lot/ Intermediate Disposition

  • Participate in bulk shipment oversight activities.

  • Participate in Quality release activities of manufactured intermediates.

Deviation/CAPA Management

  • Work closely with manufacturing and support groups to resolve all deviations within agreed timelines.

  • Perform deviation investigation activities, including; GEMBA, containment, classification and initial impact assessment.

  • Support root cause analysis for deviations related to equipment, utilities, facilities, metrology and validation.

  • Assist in deviation/nonconformance identification and resolution. May act as team member to investigate deviations to determine appropriate root cause and CAPAs.

Quality Engineering Responsibilities:

  • Work with functional groups across the site to review and approve quality and technical documentation including: deviations, CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation.

  • Review unscheduled maintenance and facility alarms, specifically the return to service testing and assessing potential impact to product.

  • May provide support for visual inspections of vessel surfaces, when required.

  • Assist in the development of robust maintenance procedures.

Additional Responsibilities:

  • Participant in internal audits.

  • Participant in Lean initiatives to improve Quality processes.

  • Participant in QA audit readiness program as well as assist and participant in external audits and regulatory inspections.

  • Participate in the QA consistency meetings to drive continuous improvement efforts.

  • Support the QA on the floor initiatives which includes; attending daily MDI meetings and assisting customers with resolution of issues in real time.

  • May provide training to new employees.

Knowledge, Skill, and Requirements:

  • Bachelor's Degree and 5 years of experience, Or equivalent experience.

  • Minimum 1 year experience within Quality Control, Manufacturing, or equivalent role.

  • Solid understanding of US, EU and ROW cGMP guidelines and requirements.

  • Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.

  • Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment

  • Ability to understand operational documents for GMP compliance, accuracy and completeness. Ability to work by influencing a matrix management system and to gain the cooperation of others.

  • Strong client-facing interpersonal skills coupled with a concern for impact.

  • High initiative.

  • Rational Persuasion

  • Strong time management and organizational skills.

  • Pragmatic, proactive yet flexible approach in the working environment.

  • Excellent written and oral communication skills both internal and external.

  • Able to manage multiple priorities and demonstrate self-control

  • Ability to resolve conflict within project teams.

  • Good leadership skills.

  • Strong attention to detail

  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

  • proficient at public speaking, teaching, facilitating to peers, senior associates, and area management within their operational group.

Physical Demands:

  • Ability to gown and enter clean rooms.

  • Requires extended time in manufacturing areas

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
QA Specialist Quality Systems

Akebia Therapeutics, Inc.

Posted 6 days ago

VIEW JOBS 4/3/2020 12:00:00 AM 2020-07-02T00:00 The QA Specialist, Quality Systems role is the primary person responsible for supporting day-to-day operations of the quality system, including facilitating the management of deviation, CAPA, change control and other quality records. They will also support other Quality Management System initiatives as opportunities arise. The QA Specialist reports to the Senior Manager of Quality Systems in supporting all activities related to Quality Management Systems. Required Skills Under the guidance of the Senior Manager of Quality Systems, the candidate will: * Support daily maintenance and visibility for the Deviation & Investigation, CAPA, Change Control, Complaints programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to: * Maintaining and supporting Quality Systems processes and systems. * Support a strengthened level of quality content within quality records * Effectively communicate and follow up on quality records with owners/functions * Maintain appropriate filing/storage for any original, non-electronic files * Maintain archive database for accuracy of quality record details and location. * Support efforts during regulatory inspections, including 3rd party inspections at vendor sites. * Retrieval of historical quality records, where applicable * Manage business admin activities in Veeva QMS * Support and advise end users on Veeva QMS processes and workflows. * Participate in quality and process improvement initiatives and project teams. * Identify opportunities for process and system improvement and enhancement. * Prepare and analyze metrics for management review and escalation of issues. * Evaluate questions and issues received from end users, support and follow up with users based on established processes, procedures and guidelines, and escalate to management as appropriate. Required Experience Basic Qualifications: * Bachelor's Degree in scientific discipline and 2+ years of quality assurance related experience. * HS Diploma or equivalent and 4+ years of quality assurance related experience. Preferred Qualifications: * Proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments. * Comprehensive knowledge of good documentation practices * Knowledge of quality assurance principals, best practices, and quality systems * Demonstrated ability to coordinate process improvement initiatives and quality system related projects. * Knowledge of both domestic and international cGMP, GCP and other relevant regulations. * Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors and consultants. * Admin experience with Veeva QMS a plus Akebia Therapeutics, Inc. Cambridge MA

Specialist Iii, QA Ops

Thermo Fisher Scientific Inc.