Quality Assurance Project Manager

Biotelemetry, Inc. Rochester , NY 14618

Posted 2 months ago

BioTel Research is a division of BioTelemetry, Inc., the leading remote medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care. Recognized as an industry pioneer, we are experienced in all phases of clinical trials, across all major therapeutic areas and all global regions. We are experts in medical imaging and cardiac safety, and have the unparalleled capability to test drugs and devices from early research through post-marketing surveillance. We are passionate about connecting people with solutions that save lives, and our growth reflects our focus, commitment and passion for the important work we do each day. As one of the fasted growing connected health companies in the market, we are looking for people to join our team who share our passion and focus.

Quality Assurance Project Manager

Overall Job Summary:

The Quality Assurance Project Manager (QA PM) is responsible for supporting the management and oversight of Corrective and Preventive Action (CAPA) activities in the Quality Assurance and Regulatory Affairs team. These responsibilities include coordinating investigations, writing CAPA plans and the ongoing monitoring of pending actions. Additionally, the QA PM will be responsible for supporting other Quality Assurance and Regulatory Affairs processes as needed, such as audits (internal/external), deviations, letters to file, etc. They will also provide guidance on quality and regulatory compliance requirements as needed. Finally, they may assist with different process improvement initiatives including revising current procedures, cross-departmental discussions, and organizing completion of actions.

Essential Duties/Responsibilities

  • Support management of Corrective and Preventive Action (CAPA) activities including logging, conducting investigations, and writing CAPA reports and ongoing monitor activities

  • Develop and maintain CAPA metrics

  • Lead and coordinate process improvement initiatives, as needed

  • Support Deviation, Letter-to-File and Audit (Internal & External) processes

  • Provide guidance on quality and regulatory compliance related requirements

  • Work with and assist the Quality Assurance and Regulatory Affairs team, as requested

  • Assist with special projects, as required

  • The physical demands are representative of those an employee encounters while performing the essential functions of this job program

Education and Experience Requirements:
  • Education: BS/BA degree or equivalent experience required.

  • Relevant Work Experience:

  • Three or more years of experience working in pharmaceutical, medical device, biopharmaceutical, or equivalent regulated field - required

  • Experience in driving business results (metrics), managing projects, and facilitating cross functional teams.

  • Knowledge of QA/RA processes such as CAPA, Deviation, Audits, Documentation Control, etc.

  • Licenses/Certifications: N/A

Required Knowledge, Skills, and Abilities:

  • Knowledge/Abilities -Technical Skills:

  • General understanding of 21 CFR Part 11 and other FDA regulatory requirements (especially those associated with clinical trials), GCP and ICH guidelines and directives is desired

  • Ability to work with data spreadsheets, select metrics and identify trends

  • Highly developed investigational skills

  • Ability to work in groups and individually with little supervision

  • Computer literacy and training and experience in Microsoft Office products, required

  • Communication Skills (Verbal/Written):

  • Excellent written and verbal communication skills.

  • Demonstrated ability to communicate effectively and constructively across departments.

  • Management/Leadership Skills:

  • Strong leadership skills.

  • Customer Service: WECARE - BioTelemetry based customer centric program

  • Other:

  • Ability to initiate and manage multiple tasks.

  • Ability to work as part of a team, meet deadlines & take instruction from multiple persons.

  • Extensive experience leading projects to completion.

EEO/AAP - Biotelemetry provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

NOTE: This job description is not intended to cover or contain a complete listing of all duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

#LI-SG1

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Assurance Scientist

Thermo Fisher Scientific Inc.

Posted 3 weeks ago

VIEW JOBS 11/4/2020 12:00:00 AM 2021-02-02T00:00 Job Description Job Title: Product Design Engineer Requisition ID: 132687BR Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 productivity in their laboratories, we are here to support them. Location/Division Specific Information This position is located in our Rochester, NY campus and supports the Laboratory Plastics (Disposables) business. How will you make an impact? The Quality Assurance Scientist will have the responsibility for planning and executing protocols and product release testing in support of operations. They will work with product development to incorporate new product release testing into Rochester's systems. The Quality Assurance Scientist's primary duties will consist of sterility product validation, maintenance and monitoring of sterility, product stability management (coordination of testing, planning, scheduling) and product release testing. The scientist should possess a wide-range of experience and uses professional concepts and company objectives to resolve complex issues in creative and effective ways. May lead processes, projects, or initiatives that are critical to the success of the function or discipline. Networks with key contacts outside own area of expertise. What will you do? * Provide oversight to Rochester Campus to ensure we are following company standards, and compliant methods for the following: bioburden monitoring, sterility testing, dose audits, environmental monitoring, clean room practices, and bacterial endotoxin testing. * Develop protocols for re-validation of radiation and ethylene oxide sterilization to support operations * Develops protocols and executes testing for laboratory equipment qualifications, test method validations, and generates test reports * Coordinate and perform required inspections, checks, analysis, and documentation of studies. * Perform data analysis, trending analysis, publishes test reports, and communicate results to management. * Maintains and updates the stability study and interval tracking system. Creates and distributes status updates for stability studies. Coordinates external testing as needed. * Perform annual requalification activities (documentation, profiling, equipment related non-conformances and out of tolerances, etc.) associated with sterilization equipment and issue resolution. * Provide scientific leadership and serve as a Subject Matter Expert (SME) in the area of microbiology across the Rochester campus, using a collaborative approach in areas of production, laboratory, sterilization, facilities and utilities. * Lead and document laboratory out of specification investigations and assist with trouble-shooting laboratory experiments. Implement CAPAs as needed. * Participate in internal and external audits as needed. * Build internal and external networks to expand knowledge outside of your own expertise to support of Rochester Operations. * Travel up to 10%. How will you get here: Education BS /MS in Microbiology, Biology or other scientific related field and a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and an advanced degree with related work experience. Experience * Experience with current standards related to microbiological techniques for the continued maintenance of sterility, product sterilization and medical devices. * Experience with ethylene oxide, radiation, steam sterilization validation * Knowledge of FDA, ANSI/ AAMI, ISO and USP radiation and ethylene oxide sterilization and microbiological standards and guidance's. * Knowledge of product evaluation methodology for determining testing required or when to apply product adoption Knowledge, Skills, Abilities * Excellent written and oral communication skills * Knowledge of product evaluation methodology for determining testing required or when to apply product adoption * Ability to work effectively and build and maintain collaborative relationships with individuals and teams across functional boundaries at all levels of the organization. * Ability to communicate effectively, both verbally and in writing, with internal and external customers * Working knowledge of ERP Systems (SAP), CAPA (TrackWise), and Document Control (MasterControl and/or Agile) is preferred Our global team of more than 75,000 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 visit www.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. Thermo Fisher Scientific Inc. Rochester NY

Quality Assurance Project Manager

Biotelemetry, Inc.