Quality Specialist II

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons - with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fast-growing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Join Thermo Fisher Scientific to support the Quality function for commercial secondary packaging and labeling and serialization of cold chain commercial drug products. This role includes oversight of the design development qualification documentation and implementation of secondary packaging processes. This role also supports storage and distribution of clinical materials.

A Day in the Life:

• Support Quality oversight and input for multiple project tasks from inception to completion.
• Review/approve documentation supporting secondary packaging of commercial products including process FMEAs Validation Project Plans Master Batch Records Standard Operating Procedures Client Work Instructions Material Specification Label Specifications and Validation Protocols.
• Host GMP compliance audits and provide Quality input for client visits and tech transfer meetings.
• Support problem-solving of operations-related issues.
• Collaborate on deviation investigations change controls corrective/preventative actions and continuous improvement activities.

Keys to Success:

Education

• Bachelors Degree in a scientific/technical field (i.e. Biology Chemistry or Engineering)

Experience

• Minimum 3 years experience in a GMP regulated facility.
• Prior experience in pharmaceutical setting.
• Existing knowledge and proven competence with secondary packaging of pharmaceuticals and/or biologics and serialization.

Knowledge Skills Abilities

• Capable of supporting simultaneous projects of varying complexity.
• Excellent self-management prioritization and governance skills.
• Detailed knowledge of cGMPs for biologics pharmaceuticals regulations and/or medical devices (21CFR Part 210/211/820/58) and their appropriate application to assure compliance

Physical Requirements / Work Environment

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat etc.)

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. As one team of 100000 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!

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-*. 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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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