Quality Specialist II
Quality Specialist II
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Loud Noises (Equipment/Machinery) Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.Job Description
As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our companys Total Rewards
Medical Dental & Vision benefitseffective Day 1
Paid Time Off & Holidays
401K Company Match up to 6
Tuition Reimbursement eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Essential Functions:
1. Serve as Quality contact and lead on resolution of incoming quality issues. Provide review and approval where applicable to incoming materials.
2. Develop solutions to complex issues and Quality initiatives with interorganizational impact. Follow cGMP regulations and company standards.
Develop and train personnel and internal customers on relevant business processes.
3. Serve as the Quality representative on crossfunctional and multisite teams.
4. Lead department and crossfunctional initiatives including maintenance of the reduced testing program in collaboration with Quality Control.
5. Troubleshoot and advise the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
6. Serve as a technical subject matter expert (SME) in support of department functions. Participate as a Compliance representative in team meetings. SME on compliance issues independently raises compliance issues with the team.
7. Review and approve controlled documents relating to processes equipment facilitiesand utilities in the manufacture of product.Review and approve change requests.
8. Provide guidance to internal and external customers on standard processes for maintaining
a supplier quality program (including selfaudit and supplier quality)
9. Provide technical assessment and approval for controlled document change provide Quality oversight to internal and external customers. Provide input into the design and presentation of departmental performance metrics.
10. Administer document and maintain the companys Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems and tools.
11. Notify Management of potential quality or regulatory issues that may affect product
quality or regulatory compliance. Approve documents for activities as authorized and described by policies procedures and job descriptions.
12.Perform other duties as required
Education:
Prefer BS degree in Chemistry Biology or related scientific subject area; will consider Associates Degree (AA/AS) with 68 years relevant experience.
Experience:
Prefer 2 years direct experience in regulatory affairs/Quality Assurance
Equivalency:
Equivalent combinations of education training and meaningful work experience may be considered
Competencies:
Establish work priorities to meet targets and timelines
Handle challenging priorities and allocate adjust and optimize assigned department resources
Sound knowledge of cGMPs or equivalent regulations
Ability to interpret and relate Quality standards for implementation and review
Ability to make sound decisions about scheduling allocation of resources and balancing priorities
Ability to communicate clearly and professionally both in writing and verbally
Flexibility in problem solving providing direction and work hours to meet business objectives
Knowledge of GMPs/QSRs and other relevant compendia.
Able to interpret and apply to operations.
Leads projects and works with management to acquire resourcing.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
