Sr Quality Specialist, Manufacturing QA
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Company information

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiencies in their laboratories, we are here to support them. Our organization of more than 100,000 colleagues globally delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Group/division summary

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

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 you will do

• Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.
  
• Ensure 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.
  
• Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity
  
• Perform quality review and approval of deviation and change control of moderate to high complexity
  
• Conduct 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.
  
• Act as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
  
• Perform QA batch disposition (release decisions)
  
• Work on issues of moderate to sometimes high complexity regarding compliance of processes and product within facilities, equipment, manufacturing and support areas.
  
• Make decisions while taking into account level of risks in regard to compliance and product quality.
  
• Lead projects of moderate to high complexity in scope and compliance-related challenges to implement procedures and processes to meet changing regulations.
  
• Follow all job-related safety and other training requirements.
  

Qualifications

• Bachelor degree required, preferably in technology, engineering, scientific related field or related field.
  
• 5+ years of experience with previous experience in Quality Assurance, Quality Control or Operations/Manufacturing is preferred.
  
• Equivalent combinations of training, and meaningful work experience may be considered if at least a bachelor degree is acquired.
  

Knowledge, Skills, Abilities

• Effective time management and prioritization skills.
  
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
  
• Outstanding attention to detail and organizational skills.
  
• Highly effective verbal and written communication skills (legible handwriting).
  
• Leadership and Presentation Skills
  
• Strong Negotiation Skills
  
• Fluent in the English language.
  
• Demonstration of active listening skills.
  
• Technical Writing Experience
  
• Self-starter, mature, independent and conscientious. Ability to work in a fast-paced environment under pressure, able to multi-task and is results driven. Demonstrates ability to maintain a high degree of confidentiality.
  
• Requires discretion and independent judgment.
  
• Ability to lead, support & empower a team
  
• Effective persuasion, negotiation ability
  
• Ability to command authority and remain firm in complex situations
  
• Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS
  
• Demonstrated Commitment to our fundamental principles of Integrity, Respect, and Excellence.
  
• Understanding of the Quality systems and investigation documentation
  
• Ability to adapt to a changing environment quickly and easily
  
• Ability to respond disciplined and rationally under pressure
  

Skills You'll Use Every Day:

Put the Customer First - Think and act with a customer-centric mentality to deliver exceptional customer experiences. Be Responsible For Your Results - Take personal accountability for all you do and always exercise good judgement. Find a Better Way Every day - Be intellectually curious and adopt Practical Process Improvement (PPI).

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific). 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.
  

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