Sr Quality Specialist Jobs

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.

Location/Division Specific Information

Our Greenville, NC facility is a large-multipurpose pharmaceutical manufacturing and packing campus that supports the Drug Product Division.

How will you make an impact?

Provides technical leadership and Quality oversight for a Sterile Manufacturing Environment in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. Ensures full compliance of the Company can operate without regulatory actions that impede product quality, cause product stoppages or reduce customer satisfaction.

What will you do?

• Makes decisions while taking into account level of risks in regard to compliance and product quality.
• Acts as a technical resource for support of new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
• Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
• Performs QA batch disposition (release decisions)
• Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.
• Performs quality review and approval of procedures, training documents, and forms deviation and change control.
• Aligns with all job-related safety and other training requirements.
• Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
• Works on issues of high complexity regarding compliance of processes and product within facilities, equipment, manufacturing and support areas.

How will you get here?

Education

• Bachelor degree required, preferably in technology, engineering, scientific or related field.

Experience

• Experience in a Sterile Manufacturing environment strongly preferred.
• A minimum of 5 years of Quality Assurance or Operations experience in the pharmaceutical field, or highly regulatory or a GMP environment.

Knowledge, Skills, Abilities

• Demonstrates ability to maintain a high degree of confidentiality.
• Self-starter, mature, independent and diligent. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.
• Strong negotiation skills.
• Highly effective verbal and written communication skills .
• Leadership and presentation skills.
• Technical writing experience.
• Ability to command authority and remain firm in sophisticated situations.
• Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS.
• Effective persuasion, negotiation ability.
• Demonstration of active listening skills.
• Effective time management and prioritization skills.
• Outstanding attention to detail and interpersonal skills.
• Understanding of the Quality systems and investigation documentation.

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 team of 100,000+ 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.