Quality Control Scientist

About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options. CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.

More information can be found at www.coopersurgical.com. The Life Science Quality Control Engineer/ Scientist III is primarily responsible for establishing, developing, implementing, maintaining, and improving laboratory processes and QC programs to include designing, developing and implementing visualization tools defining statistical quality control metrics to ensure resulting confidence and performance consistency. The Quality Control Engineer/ Scientist III will partner with stakeholders to improve the quality of the processing and output of data.

The individual is expected to work side-by-side with laboratory scientists to analyze and interpret processing data, generating insights for operational partners. The QC Scientist III will be expected to facilitate meetings aiding in the review of processing data and interpretation and providing support in the day-to-day processing and investigations for Deviations, Nonconformances and CAPAs. The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.

Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect. Implement, test, maintain, customize available/known informatics resources and scientific software/data sources in multiple programming languages/platforms for research support. Develop front ends for other analysis tools, visualize/compile results, facilitate generally defined routine data processing/migration/organization/management tasks, and build project specific workflows implementing automated analysis steps.

Investigate, customize and prototype for new bioinformatics resources and scientific software for biomedical data processing. Requires skills in multiple programming languages, databases, computational methods, scientific computing, large scale data analysis, and biomedical data from multiple sources. Use of software engineering skills towards creating reusable, modular, tested, version-controlled, shared repository oriented, professional quality informatics/software/database resources.

Design, develop and deploy Quality Control data metrics model to ensure the performance and output of laboratory processes are maintained within specification. Collaborate with laboratory scientists, laboratory data management team and other subject matter experts to provide statistical support for clinical laboratory processing and research projects involving laboratory data. Generate written summaries for use in the customized statistical lab reports.

Responsible for the build out of the real time dashboards ensuring proactive QC review prior to the release of results. Maintain functional understanding of standard policies and procedures and complete required training in a timely manner; Contribute to the development and maintenance of standard procedures and related quality control laboratory documents ensuring the accuracy and reliability of results Contribute to and review study documents including protocol drafts, statistical analysis plans, and other documents as required. Collaborating closely with operational teams to integrate bioinformatics analyses into laboratory process and interpret results effectively Facilitating meetings, providing data from tracking and trending, leading quality and continuous improvements.

Prepare reports for internal and external communication of results Develop and implement tools for custom sets of NGS data, including alignment, barcoding, and analysis/quantification. Create visualization tools and define statistical metrics for confidence. Work closely with the software engineering team in development and deployment of both automated production systems and scientist-driven data analysis platforms Provide guidance on experimental protocol design geared toward powering data insights, including scale and quality thresholds Develop novel computational methods for analyses of multi-omics data; identify gaps in existing methods/tools and develop novel solutions to bridge them.

Identify new proactive computational data metrics that can aid in process and product improvement opportunities. Build and implement computational biology capabilities to translate biological data into insights. Foster a driven, fast-paced, dynamic, and fun environment in which to do rigorous science Maintains a culture of awareness, teamwork, and cooperation with Operation customers.

Travel: ☒ Hybrid (1-3 days a week onsite) ☒ Onsite (Livingston, NJ USA) LL-DD1 Master's Degree in Bioinformatics/Computer Science/Bioengineering/Computational Biology or related field. Six Sigma Certification a plus. Over 4 years of experience working as a biostatistician in the pharmaceutical, biotechnology, or medical device industry.

Solid grounding in molecular biology, genetics, and statistical methods. Experience in non-clinical statistics, laboratory testing and/or manufacturing process control Demonstrated ability to understand and implement computational algorithms, statistical analysis methods, custom data analysis software. Demonstrated proficiency in software development in multiple programming languages, such as Python/Java, and derivatives.

Demonstrated proficiency in software engineering processes, such as version control, backup, documentation, testing, validation. Demonstrated proficiency in downloading/learning/applying software and database resources for custom analysis and building workflows. Demonstrated proficiency with scientific computing and data visualization tools and understanding of basic statistics.

Demonstrated familiarity with large-scale data analysis and utilization of high-performance computing systems, parallel programming. Demonstrated proficiency with NGS workflow processes and languages. Excellent verbal and written communication skills Collaborative personality with strong interpersonal skills Ability to work effectively in a cross-functional, team environment that includes computational biologists, statistical geneticists, bioinformaticians, engineers, and program managers - either as an individual contributor or as a technical lead As an employee of CooperSurgical, you'll receive an outstanding total compensation plan.

As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team. To all agencies:

Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.