Job Details

ID #17102959
State Wisconsin
City Madison
Full-time
Salary USD TBD TBD
Source Promega
Showed 2021-07-21
Date 2020-10-26
Deadline 2020-12-25
Category Science/biotech
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Sr QA Scientist, Validation

Wisconsin, Madison, 53701 Madison USA

Vacancy expired!

Job Description:

Promega is an international bio-tech company with over 4000 high quality products that have been supporting science for over 40 years. We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests - and that’s just the beginning. And yes, we have been extremely busy providing our technologies to support COVID-19 testing and research.

We strive to create an open, inviting and inclusive culture – we care about you as a person, not just a team member. We embrace the principles of emotional and social intelligence – which helps our employees improve relationships, manage stress and enhance connections. Establishing and maintaining relationships is part of the foundation of our culture - teams are more like family than co-workers.

Our campus speaks volumes. Headquartered in Madison, employees work in and around a campus with multiple buildings that are integrated into a natural setting with trails, ponds, woods and a restored prairie. Sustainability is important – we invest in energy efficiency and use renewable energy. Our culinary team offers top notch food to employees – including an onsite garden to supply fresh produce. Check out our campus through this map, and learn more about our people and sustainable practices.

OUR TEAM:

We are a passionate team of Scientific/Engineering professionals responsible for the Promega Validation program. This multidiscipline team manages Equipment Qualification, Method Validation and more.

YOUR ROLE:

You are our go-to for equipment qualification of equipment used to manufacture medical devices. You have a passion and demonstrated experience establishing procedures for validating equipment and

processes, evaluating risk and serve as our expert on all things validation related.

YOUR EXPERIENCE:

You have an extensive background in IVD/Medical device validation, including molecular method and process validation. Ideally your experience would include filling, packaging and other manufacturing equipment. You are a complex thinker and have the ability to communicate across all levels of the organization. Strong cross functional teamwork experience is desired.

Ideal candidates will have experience in:

  • IVD / Medical device validation
  • Experience with equipment qualification of equipment used to manufacture medical devices
  • Experience with Molecular method validation
  • Experience with Process validation including filling packaging and other manufacturing

JOB OBJECTIVE: Support validation activities required for QSR compliance.

ESSENTIAL DUTIES:

1. Implement and Coordinate Validation Activities in Support of QSR-Compliant Manufacturing.

2. Establish procedures for validating equipment, processes and QC methods.

3. Create process maps for manufacturing and QC processes; utilize maps for validation planning.

4. Write Product Master Validation Plans, Qualification Protocols, and associated reports.

5. Review Product Master Validation Plans, Qualification Protocols, and associated reports.

6. Evaluate changes to validated processes.

7. Execute validation activities when appropriate.

  • Review and approve batch records, stability data and validation results to ensure that products meet requirements.
  • Review and approve technical literature content for accuracy and consistency.
  • Assess the scope and inventory impact of nonconforming product situations; approve disposition plans of inventory product on Hold and assist in the disposition planning for nonconforming product in branch inventories.

8. Serve as backup for QA Review function.

9. Review and approve manufacturing and testing plans for specified custom products.

10. Write SOPs as appropriate.

11. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk.

12. Prepare and implement training plans in areas of expertise and experience.

13. Understand and comply with ethical, legal and regulatory requirements applicable to our business.

MANDATORY QUALIFICATIONS:

1. BS or higher degree in appropriate life science, chemistry, or engineering field.

2. Minimum of 6-10 years experience in the Pharmaceutical or Medical Device industry. Experience must be in manufacturing, process development, quality control or quality assurance.

3. Minimum of 3-5 years experience in equipment qualification, process validation and test method validation in a regulated field.

4. Able to develop concise, clear written communication and presentations that contain both analysis and possible solutions.

5. Proven ability to work constructively with a broad range of people, including the ability to compromise and negotiate win-win solutions.

6. Proven ability to work constructively with a broad range of people, backgrounds, and functions.

7. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors

8. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

9. Proficiency with basic word processing and spreadsheet software

10. Lead or assist with department or corporate projects as assigned in a positive team environment.

11. Ability to work under moderate supervision.

12. Effectively prioritize and manage workload in an environment with frequent interruptions and changing priorities and timelines

13. Ability to apply effective critical thinking skills in problem solving and decision making to achieve positive results.

14. Ability to embrace conflict and effectively resolve and build relationships by guiding others in a professional and positive manner.

15. Effectively communicate and align department goals and strategies to meet objectives and action plans.

PREFERRED QUALIFICATIONS:

1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications.

PHYSICAL REQUIREMENTS:

1. Visual acuity required for physical inspection of finished product and raw materials and accompanying documentation.

2. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, protective gloves).

3. Ability to use computers in an interactive manner for extended periods of time.

Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

Vacancy expired!

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