Sr Site Specialist -QC Lab Support - West Greenwich, RI

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $50 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 in their laboratories, we are here to support them.

Location: West Greenwich, RI

Hours: first 6 months, M-F, 7:30 - 4:00, then after that it would be flex shift

We offer:

Competitive Pay:

$27.05 per hour (includes shift differential)

Excellent Benefits!

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

For more information on our benefits, please visit:

Paid Time Off & Holidays

401K Company Match up to 6%(after 1 year)

Tuition Reimbursement – eligible after 90 days

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

We will provide the vital equipment for your role including: computer, monitor, keyboard, mouse, etc.

We also provide any Personal Protective Equipment you may need including: lab coats, safety glasses, safety shoes, etc.

How will you make an impact?

This position supports Quality Control. Excellent custom service skills, data integrity, working with various systems are essential.

What will you do?

The STAT titer portion of this role directly supports commercial manufacturing.

During coverage for STAT Titer, this position works variable shifts including second shift, third shifts, nights, weekends, and holidays in order to accommodate the manufacturing schedule.

Job-Specific Duties may include:

Use of validated electronic laboratory sample database to create samples, and maintain sample inventory within a LIMS system

Operator level gowning for entrance and work performed in manufacturing suites

Sample preparation of drug product and drug substance

Operation of Waters and Agilent HPLC analysis systems using SEC, IEC, RPC, and Affinity chromatography methods

HPLC Analysis for Purity, Identify, and Concentration (PIC) for STAT and non-STAT samples

Perform first level troubleshooting on HPLC systems, including change out of external and internal components

Interpret HPLC result data for molecule PIC based Method acceptance criteria

Independent data verification of HPLC analysis product for PIC

Communication with manufacturing management analysis results for forward processing of commercial product

Perform Biological Indicator testing on manufacturing samples for microbial growth

Align with safety guidelines and regulatory requirements

Ensures that, equipment, materials, processes, and procedures align with cGMP practices and other applicable regulations

Alerts Customer management of quality, compliance, supply and safety risks

Completes required assigned training to permit execution of required tasks

Utilization of Good Documentation Practices in all record keeping

Maintaining metric data for work performed

Perform equipment verifications and calibrations following customer and manufacturer’s protocols

Maintain Quality Control reagents within customer validated Consumable Inventory Management System (CIMS), including adding reagents, uploading C of A, determination of chemical equivalents, crafting sub-inventories, and discarding of items

Strict adherence to customer Standard Operating Procedures and Method protocols

Perform primary trainer responsibility for customer validated Methods and procedures

Promote a safe work environment through various safety initiatives within functional area

Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods, and leading team meetings

How will you get here?

Education:

Bachelor's Degree is required

Experience:

1+ year of laboratory experience, preferred

Knowledge, Skills, & Abilities:

Ability to work a flex schedule is required

Evident understanding of intermediate HPLC principals

Requires proof of COVID-19 vaccination

Must maintain Thermo Fisher Scientifics’ Four-I Values.

Demonstrates a strong desire to serve the customer and the social skills to team with various levels of personnel at the customer site.

Must deliver excellent customer service to include maintaining a professional appearance at all times.

Operating skills to use hand held devices and learn to enter data in various systems as needed.

Efficient intermediate skills in Microsoft Office suite of software.

Experience in laboratory settings and GLP/GMP environments, preferred.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not a comprehensive list of all the duties and responsibilities associated with it

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.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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