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Thermo Fisher Scientific Quality Assurance Specialist II in Alachua, Florida

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

The position is client facing and is called upon to represent quality assurance in client meetings, internal and external regulatory audits, and updates. To perform this job successfully, the individual must have sound knowledge and experience in the application of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations.

The Individual is responsible for performing technical Quality Assurance activities supporting cGMP production and provides routine updates on outstanding commitments.

What will you do?

  • Primary responsibilities are in the review of GMP processes, documents and records pertaining to Quality Control, including methods and results, specifications, stability, Assay Qualification and Validations, microbiology and Environmental Monitoring including trending data.

  • Supports GMP Facilities, including equipment, automation, computerized systems and utilities qualification and validations, calibration, preventative maintenance and monitoring.

  • Performs robust document review and approval activities to meet specified timelines and ensure the adherence to Quality Agreements, regulatory requirements and site procedures. Tracks review and cycle times of relevant records. Documentation may include test records, protocols, reports, batch records, SOPs, investigations, corrective actions, change controls, and technical documents.

  • Reviews paper based and electronic systems and data in accordance with site procedures.

  • Provides QA support on investigations, CAPAs and Change controls, particularly related to Quality control, Microbiology and Facility activities. Reviews and assesses criticality of events/investigations as required by the applicable procedure and client quality agreements.

  • Works collaboratively with manufacturing, QC, Supply Chain, Facilities & Engineering and cross-functional stakeholders to complete exception investigations, CAPAs and Change controls appropriately.

  • Performs internal audits of all GMP compliant operating departments according to schedule or as needed. Reviews records, writes audit reports and verifies completion of agreed actions or responses.

  • Provide support during client audits and regulatory inspections.

  • Participates in client meetings and acts as Quality representative for ensuring program compliance.

  • Assists with the improvement of quality compliance by recognizing continuing issues and bring them to QA managements attention. Helps to create procedures or processes to fulfill quality related improvements.

  • Supports the maintenance of systems used to track audits, inspections, responses, corrective actions, preventative actions, etc.

  • Supports QA in the areas of batch record review and Product release as needed and directed by supervisor.

How will you get here?

Education:

  • Minimum Requirement: Bachelor’s Degree – preferred focus of study: Life Sciences or Chemical / Biochemical Engineering

Experience:

  • Minimum 3+ years GMP industry related experience

  • Understanding of applicable regulatory requirements

Knowledge, Skills, Abilities:

  • Strong interpersonal and communications skills; written and oral

  • Knowledge of FDA/EMA/ICH/JP regulatory requirements applicable to pharmaceutical Quality Systems.

  • Ability to apply GMP regulations and other international guidelines to all aspects of the position.

  • Responsible for working with subject matter experts to generate or update quality training and documentation.

  • Authors or revises SOPs as necessary.

  • High attention to detail and concern for standards are required.

  • Critical thinking with the ability to prioritize multiple projects simultaneously

  • Experience with Quality Control and microbiology, particularly in Assay Validation, a strong plus.

  • Knowledge of QbD, Risk Based approach, and performing Risk Assessments

  • Must be skilled in the use of a personal computers and related software applications.

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

  • Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group as well as to external clients.

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

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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