21 days old

Manager, Document Control & Training

Lansing, MI 48933


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

MANAGER, DOCUMENT CONTROL & TRAINING

Emergent BioSolutions is currently seeking a Manager, Document Control & Training for our Lansing location. The successful candidate will have a bachelors degree in a life sciences or education related field, a minimum of five (5) years of cGMP experience and a minimum of three (3) years of cGMP Quality experience. The ideal candidate will have experience with electronic document management, learning management, non-conformance, CAPA, and change control systems. Must be proficient in MS Office products. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

THE COMPANY

Emergent BioSolutions is dedicated to one simple missionto protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

THE OPPORTUNITY

The Manager, Document Control and Training, is responsible for ensuring the efficient and effective execution of work within the Document Management and Learning Management systems to support business operations while remaining compliant with all applicable GxP regulations.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Document Control

  • Direct employees in day-to-day activities relating to the Document Control department to ensure work is compliant with regulations and standards to support business operations.
  • Responsibilities include (but are not limited to) document formatting/processing, batch production record issuance, records maintenance, improvement projects, and internal customer service.
  • Local ownership and oversight of the electronic Document Management System.

Training

  • Direct employees in day-to-day activities relating to the Training department to ensure work is compliant with regulations and standards to support business operations.
  • Responsibilities include (but are not limited to) assignment & removal of training from personnel, development of new and updated training materials, development of curricula for specific GMP job functions aligned with job descriptions, ensuring effectiveness of training programs, facilitation of training programs for new and existing employees.
  • Local ownership and oversight of the electronic Learning Management System.

Quality System Support

  • Serve as the local liaison to global quality system teams supporting harmonization, improvement, and information sharing efforts.
  • Identify, maintain, and report on key performance metrics supporting the health of systems as part of the Management Review process.
  • Coordinate information and record flow during regulatory inspections to complete auditor requests in a timely manner.

Management

  • All functions associated with recruitment and hiring process for EBOL Quality Assurance Support positions (full-time, part-time, temp, limited term).
  • Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
  • Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group.
  • Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable.
  • Mentor, coach, challenge, and develop team members while serving as a role model of Emergents core values.
  • Ensure the team effectively collaborates with key internal and external stakeholders, including Manufacturing, Regulatory Affairs, Engineering, Development, Supply Chain, and IT in accordance with our corporate values and practices such as Lean and Partners in Leadership.
  • Plan and track all budgetary requirements. Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel. Provide routine reports regarding budgetary updates and variances against approved budgets.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.


EDUCATION, EXPERIENCE & SKILLS:

  • Bachelors degree in a life sciences or education related field
  • A minimum of five (5) years of cGMP experience; minimum of three (3) years of cGMP Quality experience
  • Experience with electronic document management, learning management, non-conformance, CAPA, and change control systems
  • Understanding of training procedures and techniques; (i.e., needs assessment, training facilitation, presentation skills, instructional design and curriculum development, adult learning theory and delivery, evaluation of training).
  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills
  • Communication skills: listening, verbal, written, including the ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management
  • Interpersonal skills: conflict resolution, consensus building, leadership, team building
  • Personal competencies: adaptability, integrity, judgement, self-awareness, vision
  • Highly desirable to have a minimum of four (4) years of supervision experience

Interested? Please visit www.emergentbiosolutions.com<> to apply today!

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<> .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-04-27 Expires: 2022-05-27

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manager, Document Control & Training

Emergent BioSolutions Inc.
Lansing, MI 48933

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast