Quality Specialist II, Batch Record Review (2nd shift) Position Available In Pitt, North Carolina

Quality Specialist II, Batch Record Review (2nd shift) Thermo Fisher Scientific – 3.4

Greenville, NC Job Details Full-time Estimated:

$56K – $71.7K a year 4 hours ago Benefits Paid holidays Health insurance Dental insurance 401(k) Tuition reimbursement Paid time off Vision insurance Benefits from day one Opportunities for advancement Referral program Qualifications Six Sigma Certification

ISO 9001

Mid-level Six Sigma Quality assurance Presentation skills Bachelor’s degree Certified Quality Auditor Quality control QA/QC Technical writing Quality systems Associate’s degree 2 years Communication skills Time management Full Job Description Work Schedule Second Shift (Afternoons) Environmental Conditions Office 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 As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. How Will You Make an Impact? In this position, you’ll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours for this role are 10:00am – 6:30pm. A Day in the Life Assist with daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs. Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique Champion quality culture by aiding personnel in understanding application of policies and controls May support in RAPID event response and provides quality guidance for deviation events Ensure escalation of deviation events to the appropriate area and quality management Perform quality review and approval of procedures, training documents, and forms of low to moderate complexity Perform quality review and approval of deviation and change control of low to moderate complexity Participate as the quality assurance representative in Root Cause Analysis to support deviation investigations of low to moderate complexity Perform quality batch record review Aid in identification of continuous improvement opportunities; Participates in practical process improvement initiatives How will you get here? Education Associates degree required, preferably in technology, engineering or scientific related field. Bachelor’s degree preferred. Experience Up to 2 years of related experience if candidate has obtained a bachelor’s degree. 2+ years of experience in Quality Assurance or Quality control or Operations/Manufacturing Equivalent combinations of education, training, and relevant work experience may be considered Knowledge, Skills, and Abilities Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e.

ISO 9001

) Effective time management and prioritization skills. Good interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Good verbal and written communication skills (legible handwriting). Good Presentation Skills. Demonstration of active listening skills. Ability to troubleshoot process and equipment issues Ability to learn Technical Writing experience Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS Ability to develop solutions that are mutually advantageous to the client and to Thermo Fisher. Ability to function independently and part of a team. Understanding of the Quality systems and investigation documentation Ability to adapt to a changing environment quickly and easily Ability to respond focused and rationally in high pressure situations Ability to display command authority and remain firm in complex situations Physical Requirements/Work Environment 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 pound 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. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally. What We Offer 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! Compensation Competitive Pay Annual performance-based bonus Annual merit performance-based increase Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays 401K Tuition Reimbursement Employee Referral Bonus Career Advancement Opportunities