Quality Specialist III (12 hour nights)

Job Description

QA Specialist III-Night Shift 12 hrs. Rotation

POSITION SUMMARY

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.

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:

• Bachelor’s degree, preferably in technology, engineering or microbiology related field required.

• Equivalent combinations of education, training, and relevant work experience may be considered

• 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 regulated 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.

• Position requires 12 hour night shift rotation schedule (2 on-2 off-3 on)

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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/disability access

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