- Contamination control strategy (define/own/maintain for the assigned areas)
- EM program (define/oversee/improve)
- Media Fill Program (oversee)
- Aseptic Comportment/Training/Oversight (Manage)
- Sterilization processes (oversee)
- Risk assessments and improvement programs (implement/manage - against current and future expectations)
- Lead sophisticated investigations into issues impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures)
- Review & approve any Major/Critical deviations and change proposals with Sterility Assurance impact for the assigned areas.
- Staying up to date with the best approach and sharing that knowledge (10% of time should be dedicated to this)
- Act as Subject Matter Authority (SME) with regulators / clients (i.e. key part of audits)
- Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
- Implementing best practice (i.e. ensuring understanding / compliance with updated Annex - owning the transition and any risk assessments we need)
- Represent site on the Sterile Working Group, and facilitate harmonizing practices across sites in the network
- Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
- Follows all job-related safety and other training requirements.
- Minimum required education: Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar.
- 5+ years of experience Microbiology experience is crucially required for this role. (Preferably, Micro Laboratory or Environmental Monitoring experience, and ideally within a sterile pharmaceutical manufacturing facility).
- Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site.
- Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation.
- Knowledge of aseptic process simulations (media fills).
- Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be useful.
- Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial.
- Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance.
- Strong investigative skills, preferably familiar with Root Cause Analysis methods.
- Leadership experience, and supervisory experience is helpful.
- Shown expertise with audits and client-facing roles.
- Outstanding technical writing skills
- Influencing
- Strong sense of diplomacy and assertiveness
- Quality Judgement
- Effective time management and prioritization skills.
- Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
- Outstanding attention to detail and organizational skills.
- Self-starter, mature, independent and conscientious. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality.
- Requires discretion and independent judgment.
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Sterility Assurance Manager - Greenville, United States - Thermo Fisher Scientific
Description
Job DescriptionCOMPANY 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 efficiency 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 visitGROUP/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 Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation.
Key Responsibilities:
Qualifications:
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 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.
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 at 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 ACCESSJob 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 *.
Please include your contact information and specific details about your required accommodation to support you during the job application process.
