What are the responsibilities and job description for the Quality Operations Specialist III position at Thermo Fisher Scientific?
Job Description
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
At Microbial Manufacturing Services (MMS), a division of Thermo Fisher Scientific PSG Corporation (Patheon), we deliver, from process development through commercial supply, the expertise, and resources necessary to help clients deliver innovative therapeutics.
Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
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 PSG directives and procedures, customer requirements, and regulatory standards.
What will you do?
Education:
Typically located in a comfortable indoor area.
There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odors, temperature extremes, loud noise, strong drafts, or bright lights.
Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasion.
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 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.
Compensation and Benefits
The salary range estimated for this position based in California is $83,300.00-$125,000.00.
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:
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
At Microbial Manufacturing Services (MMS), a division of Thermo Fisher Scientific PSG Corporation (Patheon), we deliver, from process development through commercial supply, the expertise, and resources necessary to help clients deliver innovative therapeutics.
Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
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 PSG directives and procedures, customer requirements, and regulatory standards.
What will you do?
- Lead various site boards, e.g.
: change control board, deviation review board/CAPA board, QMR etc. - Provide SME support and/or final decision on operational quality related topic to all business functions at the site.
- Execute on all activities related to material or product disposition.
- Review, approval, and oversight of activities associated with CAPA, deviations, and change controls.
- Lead and manage projects assigned.
Able to multi-task efficiently to ensure timely project completion. - Review and approve documents including Standard Operating Procedures, Batch Records, Work Instructions etc.
- Perform daily check in with operations, through 'quality on the floor' initiative.
- Champion and implement process improvement initiatives, to meet compliance and create center of excellence.
- Issue and archive documents such as labels (as needed).
- Create/update procedures related to quality operations department.
- Perform environmental data review and release of production areas.
- Perform day to day tasks in a timely manner to meet department and business goals.
- Support internal, client and health authority inspections as needed; and support internal activities concerning any identified nonconformities (e.g., completion of audit related CAPAs).
- Ensure good working relationship with clients, and acts as a point of contact (as Manager's back up) for the clients on all matters related to quality operations.
Education:
- Minimum required education: Bachelor's degree in a Chemical or Biological Science or related technical field.
- 4-7 years experience in a related Quality position supporting the manufacturing and testing of biologics, medical device, or pharmaceutical products.
- Advanced knowledge of U.S. and EU regulations, related ICH guideline and industry standards.
- Proficient experience in ERP systems such as eDMS, Global TrackWise, SAP
- Proficiency in Microsoft Suite (Word, Excel, PowerPoint etc.
). - Ability to make operational quality related decisions independently.
- Skilled technical writer, able to convey complex topics through text and diagrams.
- Ability to train others
- Have flexibility to work various shifts times if needed to meet department or business goals.
- Self-motivated, with excellent organization skills and detail oriented.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Strong commitment to customer service and results.
- High ethical standards to support a professional business code of conduct.
Typically located in a comfortable indoor area.
There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odors, temperature extremes, loud noise, strong drafts, or bright lights.
Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasion.
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 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.
Compensation and Benefits
The salary range estimated for this position based in California is $83,300.00-$125,000.00.
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
Location/Region: Carlsbad, California
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