Supervisor, QA Nights
Thermo Fisher Scientific

Job Info

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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.

Location: Greenville, North Carolina, - This facility is a large, multipurpose pharmaceutical manufacturing and packaging campus.

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

POSITION SUMMARY

The Sr. QA Specialist for QA Material and Site Compliance will perform specialized level work assignments regarding material Quality Systems, general Quality projects, and change control as it relates to Material and Site Systems. The role will serve as an SME for Digital TrackWise and SAP site systems. The role may also support projects related to site systems to include addressing quality and compliance issues; implementing improvements in quality and compliance; and assurance of continued compliance with evolving quality and regulatory requirements.

Key Responsibilities:

• Serve as a QA approver for several aspects of the material initiation process for critical purchased materials.
• Provide site support for externally initiated changes as it relates to material and the systems that support material compliance.
• Provide QA support and approval for deviations, change controls, and corrective actions relating to site processes and procedures.
• Collaborate with the PSG & LSG global network for Supplier Management as it relates to the implementation of site changes to adopt / assess changes in Global Supplier Management processes.
• Review and approval of proposed updates to SAP Data for critical material compliance data changes.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Routine inspection of site areas to ensure support areas are audit ready.
• Communicate information and support project timelines to both internal and external customers, as needed.
• Support risk assessment evaluations as it relates to material compliance (EMRA & RRA).
• Facilitate risk assessments related to Sterile and OSD product processes.
• Support daily, weekly, or monthly material Quality Systems review to ensure site compliance metrics are maintained.
• Prepare and present site data for supplier audits and to support GRC customer audits and regulatory inspections.
• Navigate site and global quality systems to support assessments, consensus review, and oversight of change control management as it relates to materials.

Required Qualifications:

• Bachelor's degree, preferably in technology, engineering or microbiology related field required.
• 5+ years of experience with previous experience in Technical, Quality, Procurement, Manufacturing Operations, or related Business management field.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Preferred Qualifications:

• 3+ years' experience in a cGMP manufacturing environment in a Quality role, preferred.
• Experience and proficiency in SAP, Trackwise Digital, Trackwise, and MS applications (Excel, Word, Outlook, and Document Management Systems) strongly preferred.
• Proven Quality, Technical, and / or Manufacturing experience in the areas of pharmaceutical, medical device, and / or vaccine manufacturing or packaging.

Knowledge, Skills & Abilities:

• Experience in successfully leading improvement initiatives supporting related, Quality or regulatory compliance.
• Experience in purchasing and demand & supply chain.
• Experience in management, documentation, deviation, and process supervising systems preferred.
• Ability to work within a matrix organization and use expertise from other functions
• Ability to support cross-functional and multi-site initiatives involving integration
• Excellent written and oral communication skills; ability to communicate optimally with Senior Leadership and all levels below; ability to prepare high-quality presentations and deliver them effectively
• Ability to work independently with a proactive attitude to mitigate risk, prioritize, align and simplify, demonstrate passion, take accountability and drive for results
• Knowledge of cGMPs, technical writing, data management collection, and analysis
• Outstanding interpersonal skills, including collaboration, facilitation, and negotiation
• Ability to work effectively with external clients with collaborative decision making (with regards to Risk Management).

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.

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