Job Description

COMPANY INFORMATION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled 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 www.thermofisher.com.

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 would be 6A-6p, on a 2-2-3 rotating shift.

Key Responsibilities:

• Provide In-Line batch quality record reviews in the Steriles Packaging and Inspection Production areas.

• Perform document reviews and make determinations as to whether work performed meets current procedures and regulatory expectations. Communicates and coordinates with other departments to resolve issues and compliance concerns detected during review.

• Daily interaction with personnel to assist with troubleshooting, documentation

• Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance per site procedures and cGMPs.

• Provide corrections/notes, and guidance with aseptic technique

• Cultivate quality culture by aiding personnel in understanding application of policies and controls

• Participate in rapid response and provides quality guidance and quality decision making for RAPID events

• Advance deviation events to the appropriate area and quality supervision

• Aid in identification of continuous improvement opportunities; Participates in practical process improvement initiatives

Qualifications:

• Associates degree in science, technology, engineering, mathematics (STEM) or business with 4 years of experience in Quality Assurance, Quality control or Operations/Manufacturing required.

• Bachelor’s degree in science, technology, engineering, mathematics (STEM) or business, with 2 years of experience in Quality Assurance, Quality control or Operations/Manufacturing required.

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

• Experience and knowledge in aseptic or steriles processes, preferable.

• GMP's process in an aseptic area and review batch record.

• Quality and compliance understanding

• Ability to collect data, analyze and troubleshoot process issues, equipment problems along with production leadership

• Determined, proven ownership and responsibility

• Ability to lead, support and motivate a team

• Technical Writing experience

• Professional certifications (ex: CQA) and training (Six Sigma) are a plus

• Position requires 12 hour day shift schedule

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.

Apply today! http://jobs.thermofisher.com

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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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