QC Reviewer, Stability

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Role : QC Reviewer

This is a fully onsite role based at our customers site in Foster City CA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Within our Analytical Services team we have a functional service provider solution which is a unique partnership that allows our customers to leverage the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company all while maintaining full-time benefits.

This role will be onsite in : Foster City CA

Essential Functions :

Performs complex analytical data review evaluating laboratory data for compliance with analytical methods SOPs directives and scientific soundness.

Validates large and / or non-routine projects.

Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.

Determines whether laboratory staff effectively validated a particular method.

Reviews sample results for completeness and accurate representation of the data and reports findings.

Provides expert knowledge in one or more analytical techniques to assist laboratory and quality groups make informed decisions.

Communicates with laboratory staff to proactively address the quality of laboratory documentation.

Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.

Trains new QC Reviewers and laboratory staff.

Assists the departmental manager or supervisor in the evaluation of the laboratory QC program. Helps maintain compliance and assists in continuous improvement of laboratory processes.

Performs other duties as assigned.

Driving Meetings

Stability Activities include :

Stability Program Support

• Perform data analysis using JMP and Discoverant for quarterly trending and regulatory submissions.
• Generate Stability Summary Reports (SSRs) from LIMS for regulatory filings and inquiries and Shelf-life extensions.
• Verify data for non-regulatory reports and support information gathering for stability-related investigations.
• Maintain and update molecule-specific stability trackers and shipping forecasts using Smartsheets and internal systems.
• Draft temperature excursion memos and initiate stability studies through protocol creation and revision.
• Populate and manage trackers for biologics programs and monitor material transfer reports.
• Collaborate with stability leads to ensure timely and compliant execution of stability program deliverables.

Qualifications :

Education and Experience :

In some cases an equivalency consisting of a combination of appropriate education training and / or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities :

Ability to train and mentor junior staff

Ability to cultivate a collaborative work environment with a team and across business areas

Strong verbal and written communication skills

Strong attention to detail

Proven problem solving and troubleshooting abilities

Understanding of basic financial terms and definitions as it applies to the business

Ability to independently develop project proposals / plans

Project and time management skills

Proven ability to identify and implement common efficiencies across multiple programs / projects

Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs

Ability to deal with multiple and changing priorities

Ability to provide clear and concise feedback and / or documentation of results

Ability to work in a collaborative team environment

Working Environment :

Below is listed the working environment / requirements for this role :

Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and / or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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!

Compensation and Benefits

The salary range estimated for this position based in California is $67600.00$75000.00.

This position may also be eligible to receive a variable annual bonus based on company team and / or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes :

A choice of national medical and dental plans and a national vision plan including health incentive programs

Employee assistance and family support programs including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit :

Key Skills

Facilities Management,Banking,Content Writing,Customer Support,Fun,Airlines

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 67600 - 75000