Construction in Chariton, Missouri | Fast Recruitment & Job Search

Review data, identify discrepancies, and escalate issues to management

Participate in method qualification/validation activities as necessary

Analyze, document, and report experimental data in accordance with Resilience requirements

Perform method transfer and qualification activities

2-5 years relevant life science experience

Experience in mammalian cell culture

Learn new skills, procedures, and processes as assigned by management and continue to develop professionally.

OTHER SKILLS, ABILITIES, OR QUALIFICATIONS:

Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations

Accurate Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc.)

Perform tasks on time in a manner consistent with quality systems and cGMP requirements.

Practice good interpersonal and communication skills.

Medical terminology training, time management skills, organizational skills

Preferred Skills, Capabilities and Experiences:

May act as liaison between Medical Management and internal departments

This position can be filled at Utilization Management Representative II.

Manage incoming calls or post services claims work

Determine contract and benefit eligibility

Very strong direct people management/leadership experience required, including prior experience leading management level teams

Ability to translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements.

Developing and applying next generation analytics, knowledge of the marketplace, clinical insights, and customer engagement expertise to achieve outstanding results.

Sophisticated analytical and problem-solving skills; tenacity to learn, analyze, and resolve complex situations

B.A./B.S. in business, marketing, Finance, or a related field

10+ years of sales and sales leadership experience, preferably in a medical device company

At least 6 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.

Advanced knowledge of cGMP regulations and FDA/EU guidance related to biologics or cell and gene therapies.

Demonstrated experience directly supervising employees.

A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

Main responsibilities will include, but are not limited to:

Collaborate with business partners and provide meaningful guidance to help facilitate resolution of issues across organizational boundaries.

Minimum 2 years of relevant work experience

Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

Excellent written and verbal communication skills

Experience in a Quality Control setting

Experience within Biopharmaceutical or Pharmaceutical industry

Work experience in Cell and/or Gene Therapy or Biologics

Demonstrated business acumen; excellent people management and leadership skills, able to manage complex technical organizations.

Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations / assessments.

Experience in medical safety surveillance (drugs, biologics, or devices) and/or quality improvement activities is desirable.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Deep surgical insights, gather, assimilate, and translate opportunities to address unmet surgical needs to inform the Franchise innovation agenda.

Provides medical input into Target Product Profile

Preferred Experience, Education & Qualifications

Working knowledge of GLP/GCP and GxP Regulatory requirements.

Demonstrated quality experience and the ability to collaborate with and effectively influence others.

Experience in preparation and participation in regulatory authority plant/site inspections.

7-10 years of relevant life sciences quality experience within quality and/or quality-related functions.

Experience with a quality batch review and batch release.

Project management experience is preferred.

Benefits on offer for this contract position:

2+ years of QC laboratory experience

Truvault, TrackWise, eLIMS experience preferred.

Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization.

MS Office Application (Word, Excel, Powerpoint) required.

Current Healthcare Provider BLS certification or within 3 months of hire

Mandatory Abuse Reporter Certification required within 6 months of hire

Certified/Licensed as CNA (75 hour course), OR EMT-B – Preferred

High school diploma or GED equivalent

Eighteen (18) years of age or older

Ability to read, write, speak and understand English well

You have a high school education or equivalent (GED)

If you have Security, Military, Law Enforcement experience - even better!

Excellent customer service is always your top priority.

You observe, survey the area and provide reporting on activity at your assigned location.

You provide rapid response in critical situations.

You're good with reading and writing detailed reports.

Responsible for QC sample and retain management

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)

Document and perform sample management related non-conformance investigations

A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry

Solid understanding of regulatory requirements, policies and guidelines

Experience with Quality Control document reviews and regulatory inspection processes

Strong organizational and time management skills and ability to self-manage in a sophisticated, deadline driven environment

Ability to form strong, trust-based relationships with CPLG, Account Management, Franchises, Offer Development, and Contract Strategy

At the direction of management, direct and manage commercial contract terms and conditions negotiation.

Develop and maintain positive business partnering relationships with Legal, Offer Development, and Field Sales Organization.

A degree in Business, Law, Finance, or Sales & Marketing is preferred

A minimum of 8 years of business or related professional experience

Demonstrating in-depth understanding of critical issues, decision-making, and project management skills.

Experience in Marketing, Product Management, Market Research, Sales, Business Development, Licensing and Acquisitions

Decision making, in-depth understanding of critical issues, and project management skills

Contribute to the development of global brand strategies for products, services, and programs including value propositions, segmentation, positioning, and lifecycle management

Leveraging strong problem solving, organizational, communication and analytical skills.

Align customer insights with product capabilities and messaging

Familiarity with SAP, MES (electronic batch records), TrackWise (quality event management), or equivalent systems.

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Responsibilities will include but not limited to tasks mentioned above.

Minimum 2 years of relevant work experience.

Quality Assurance experience within pharmaceutical or a related industry.

Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidelines.

Experience in Pharma/Biotech/MedTech or academic research or R&D Contract Management is required

Minimum 4 years of project/program management experience (demonstrated experience with PPP/Government R&D contracting project management) is required.

Support the management of proposal and contract data in JForce, G3O’s proposal data source; upload all required proposal documents in VeevaVault

A minimum of eight years total business experience in either Government or Commercial or R&D Contracting.

A minimum of three years of working experience in Pharmaceutical and/or Medical Devices Industry is required.

Experience with organizational complexity involving various functional stakeholders is required.

Excellent verbal and written communication skills, with exceptional interpersonal, customer service, and time management skills

Provides administrative support in including calendar management, appointment scheduling and office management.

Collaborates with the Occupational Health Nurse and the site Safety Professional in medical surveillance management, as needed. .

In collaboration with OHN, partners with Human Resources, Safety and site management teams to assure integrated team approach to problem solving.

Medical Assistant Certification is required

CPR/AED, Spirometry and Hearing Conservation certification/training is required within first 90 days of employment (company provided)

Responsible for QC sample and retain management

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)

Document and perform sample management related non-conformance investigations

A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry

Solid understanding of regulatory requirements, policies and guidelines

Experience with Quality Control document reviews and regulatory inspection processes

Have met all Department of Defense SkillBridge eligibility requirements for a United States Armed Forces Service Member, is required.

Manage ongoing classroom, lab simulation, and learning technology needs as SC training needs evolve

Manage internal communications to drive momentum across Advanced Therapies SC org; Gain internal alignment with stakeholders including SC Leadership

Manage annual budget re: Short and long-term spacing and design needs.

A minimum of 4 years relevant work experience

Currently or have recently completed (within the last 6 months) a SkillBridge internship at Johnson and Johnson, is required.