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.
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:
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.
Participate in bulk shipment oversight activities.
Participate in Quality release activities of manufactured intermediates.
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.
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.
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.
Ability to gown and enter clean rooms.
Requires extended time in manufacturing areas
Thermo Fisher Scientific Inc.