- 8:00AM to 5:00PM core hours, additional hours as required.
- Requires ability to travel on a regional or national level to support the needs of the business 5% of the time.
- Conduct Quality Control inspections and reviews of Operational activities such as receiving, shipping and inventory.
- Assess for suitability, components and products and approval or rejection of incoming materials, in-process materials and drug products
- Ensure that quality documents, protocols and records are current, accurate and properly utilized.
- Oversight which ensures that developed procedures and specifications are appropriate and followed
- Monitor Operational Quality: Through consolidation of key quality characteristics of processes, trend analysis and reporting through the Quality Assurance dashboard for identification of satisfactory and/ or unsatisfactory trends and conditions, as well as monitoring resolutions to result in systematic prevention of defects and non-conformances
- Manage Continuous Improvement Activities: Drive functional strategy, the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values as part of the Fisher BioServices continuous improvement plan.
- Ensuring necessary qualification, reviewing resource needs with other functional managers for the benefit of the overall organization.
- Conduct site level audits.
- Conduct internal audit and supplier vendor audits, as necessary.
- Support the maintenance of a competency-based training program.
- Bachelor's Degree in Scientific/Technical field, or related field (i.e. Chemistry, Biology, or Engineering) preferred.
- High school diploma or equivalent required.
- 3 years of experience in a GMP or similarly regulated facility with a BS degree preferred.
- 4-5 years of GMP or similarly regulated facility without a degree required.
- 3 years cGMP hands-on experience in Quality arena is required.
- Requires knowledge of software compliance (21CFR; Part 11).
- Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
- Effective communication skills are required, both written and verbal.
- Problem solving skills are required in situations that are not procedurally managed.
- Ability to handle multiple tasks while ensuring timely and accurate completion.
- Ability to work independently.
- Knowledge of the pharmaceutical GMP regulations and their appropriate application to assure compliance with regards to manufacturing problems.
- Knowledge of cGMPs for medical devices or pharmaceuticals.
- Strong attention to detail/follow up.
- Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.
- Must have ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents and marked changes in temperature.
- May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C).
- Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.
- Must be able to use a computer up to 6 hours per day.
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Quality Specialist III - Franklin, United States - Thermo Fisher Scientific
Description
Job DescriptionAs 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
This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. Reports to the Franklin, MA site.
Work Schedule:
The QA/QC Specialist is responsible for driving the day-to-day GMP Quality Control and Quality Assurance activities for the Franklin MA Commercial site and ensures site level compliance. This position supports the continued development of GMP capability and maintenance of compliance to US FDA Quality System Regulations and performs site level Quality Control activities. Also works closely with the Maryland QA/QC Managers to ensure consistent Quality Control activities among sites.
A Day in the Life:
Education
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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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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 *. 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.
