QA Specialist III, Quality on the Floor (12-hour nights)

Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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 100,000 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, 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 are 6p - 6a, 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:

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

• 5+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required

• Previous experience in pharmaceutical industry, preferably with QA oversight experience within an aseptic or steriles filling and manufacturing operation strongly preferred. Experience in other GMP environments may be considered (i.e. ISO 9001)

• An equivalent combination of education and relevant experience may be considered.

• 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!