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 growing efficiency in their laboratories, we are here to support them. Our more than 100,000+ colleagues globally 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

The Lead QA Technician provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensures the site can operate without regulatory actions that impede product quality, cause product stoppages, or reduce customer satisfaction. Typical hours for this role ar 7:30a - 4:30p, Monday through Friday.

Key Responsibilities:

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

• Advance deviation events to the appropriate area and quality management

• Perform processes and projects of moderate complexity, ensuring adherence to current regulations with little dependence on others.

• Provide leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.

• Perform document reviews and makes determinations as to whether work performed meets current procedures and regulatory expectations.

• Communicate and coordinate with other departments as required to resolve issues and compliance concerns detected during review.

• Conduct risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

• Perform QA batch disposition (release) decisions.

Qualifications:

• High School diploma / equivalent with 5+ years of experience in Quality Assurance role in a regulated manufacturing industry and direct interaction with operations/laboratory minimally required; or

• Associates degree (in a Computer science, Chemistry, Biology, or other technical or physical/life science preferred) with 3+ years of experience in Quality Assurance in a regulated manufacturing industry and direct interaction with operations/laboratory minimally required; or

• Bachelor’s degree (in a Computer science, Chemistry, Biology, or other technical or physical/life science preferred) with 1+ years of experience in Quality Assurance, in a regulated manufacturing industry and direct interaction with operations/laboratory minimally required

• Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred

• Good verbal and written communication skills (legible handwriting).

• Ability to function independently and as part of a team.

• Ability to develop solutions that are mutually beneficial to the client and to Thermo Fisher.

• Effective time management and prioritization skills.

• Demonstration of active listening skills.

• Self-starter, mature, independent and dependable.

• Ability to adapt to a changing environment quickly and easily

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.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.