Job Description

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 .

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 Title: Supervisor, QA (Nights)

Schedule: 12-hour Nights, 6PM – 6AM on 2-2-3 schedule

Location/Division: Greenville, NC / Pharmaceutical Services Group – Sterile

This QA Supervisor is responsible for quality assurance of sterile operations with respect to manufacturing, filling, packaging, and inspection, and associated non batch specific activities in the Sterile facility for both commercial and product development services products. Oversight by the Quality "On the Floor" team provides quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.

Key Responsibilities:

• Supervise a small team of QA professionals.

• Lead self and others with respect to: (1) job performance and employee development planning and execution, (2) QA standard work execution and collaboration with other departments to meet quality system objectives, (3) quality system decision making and risk mitigation, and (4) follow procedures while providing sound QA decisions and/or recommendations.

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

• Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique. Fosters quality culture by aiding personnel in understanding application of policies and controls.

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

• Ensures escalation of deviation events to the appropriate area and quality management

• Performs quality review and approval of procedures, training documents, and forms, as well as deviation and change control.

• Participates as QA representative in root cause analysis to support deviation investigations.

• Performs batch record review.

Required Qualifications:

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

• A minimum of 1+ years of experience in a leadership function required.

Preferred Qualifications:

• Previous experience in pharmaceutical industry or cGMP environment required, preferably in aseptic or sterile processes.

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

Knowledge, Skills & Abilities:

• Makes decisions while considering level of risks in regard to compliance and product quality.

• Ability to gather data, analyze & troubleshoot process issues, equipment problems along with production leadership.

• Outstanding attention to detail and organizational skills.

• Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a team.

• Ability to work in a fast-paced environment, able to multi-task and results oriented.

• Effective time management and prioritization skills.

• Requires discretion and independent judgment.

• Technical writing skills knowledge.

• Excellent interpersonal skills, including tact to handle sensitive matters.

• Highly effective verbal and written communication skills.

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

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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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.