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Manager, Documentation & Quality Control

  • Anywhere

Company :
Mosaic Laboratories

Location :
Lake Forest, California

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
Mosaic Laboratories is in search of a Manager, Documentation & Quality Control based in Lake Forest, CA. As a member of our leadership team, you will manage and participate in the data integrity, scientific writing, document control, and quality control processes within the organization. This position reports to the Senior Vice President.

This is a full-time day shift position working Monday Friday.

Responsibilities

* Manage and provide scientific oversight to the documentation and quality control processes for the organization. This includes all data and scientific/technical documentation such as study reports, validation reports, standard operating procedures, training guidelines, instruction manuals, forms, presentations, marketing material, and publications.
* Ensure that members of the documentation team meet timelines and produce high quality documents and reports. Retrain direct reports as needed.
* Evaluate the scientific content, structure, statistics and conclusions in reports. Make suggestions for changes as needed.
* Write final reports, prepare documents and presentations.
* Develop and track performance metrics. Review findings with management.
* Administratively monitor members of the documentation team including tracking of schedules, absences, requests for time off, etc.
* Perform employee reviews for direct reports.
* Participate in quality assurance audits and address concerns immediately.
* Adhere to project timelines and expected deliverables.
* Partner with HR on recruiting, employee relations, and employee development.

Requirements

* Bachelors degree in a science related field; Masters degree or Ph.D. preferred
* 5+ years supervisory or management experience
* Experience writing scientific reports, protocols, and presentations with a high degree of technical acuity
* Experience reviewing large amounts of scientific data
* Experience with FDA and regulatory technical document submissions a plus
* Understanding of a clinical laboratory with experience in immunohistochemistry and FISH a plus
* High attention to detail
* Ability to type 60+ wpm
* Excellent written and verbal communication and grammatical skills
* Strong knowledge of Microsoft Excel, Word, and Powerpoint
* Ability to manage multiple timelines while maintaining quality of work using organizational, communication, facilitation, and interpersonal skills within a cross-functional team

Benefits

Mosaic is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world! We offer a wide range of benefits including:

* Competitive wages
* Medical, dental, and vision benefits
* Life/AD&D benefits
* Additional voluntary benefits
* 401k retirement savings plan with a healthy match
* Vacation and sick time
* Career development opportunities
* Continuing education
* Free snacks

About Us

Mosaic Laboratories is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony forming assays. Mosaic is a CLIA licensed and CAP accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices.

Join us as we make an impact on the future of patient therapy!