Sr. Quality Specialist

at  Thermo Fisher Scientific

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.

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-oriented. 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.

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