QA Specialist III, Quality on the Floor (12-hour days)
QA Specialist III, Quality on the Floor (12-hour days)
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1 Vacancy
Job Description
Work Schedule
12 hr shift/daysEnvironmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving complex analytical challenges improving patient diagnostics and therapies or growing efficiency in their laboratories we are here to support them. Our global organization of more than 100000 colleagues delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industry-leading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services and Patheon. For more information please visit .
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.
POSITION SUMMARY
In this position youll 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 are 6a - 6p on a 2-2-3 rotation.
Key Responsibilities:
Perform 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
Champions quality culture by aiding personnel in understanding application of policies and controls
Participates in RAPID event response and provides quality guidance for deviation events
Advances deviation events to the appropriate area and quality management
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
Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
Performs quality batch record review
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
Qualifications:
Bachelors degree preferably in technology engineering or microbiology related field required.
A minimum of 4 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred experience in other GMP environments may be considered (i.e. ISO 9001)
Ability to capture data analyze & troubleshoot process issues equipment problems along with production leadership
Ability to troubleshoot process and equipment issues
Hard-working demonstrated ownership & responsibility;
Ability to lead support & empower a team/peers
Technical Writing experience
Professional certifications (ex: CQA) and training (Six Sigma) are a plus
Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing walking and repetitive bending and aseptic and non-aseptic gowning.
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 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.
Benefits:
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!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
