Senior Quality Assurance Specialist - Cape Town, South Africa - Watchmaker Genomics

Watchmaker Genomics
Watchmaker Genomics
Verified Company
Cape Town, South Africa

2 weeks ago

Thabo Mthembu

Posted by:

Thabo Mthembu

beBee Recruiter
Description

Company Overview

Position Description


You will work within and support our world-class ISO 13485-compliant Quality Management System (QMS) to continue to build an industry-leading, agile genomics company with a quality-conscious customer base.

Your role will involve supporting the quality system aspects of change control, nonconformance (NC) and corrective action and preventive action (CAPA) management, batch record reviews, facilities management, qualification and validation.


How will you contribute?

  • Support a highquality and highperformance culture across the company
  • Support production quality processes, including but not limited to change control, NC management, CAPA management, data analysis and continuous improvement
  • Participate in NC or CAPA investigations related to manufacturing, testing and control systems
  • Review and approve quality documents, records and reports including production batch records, NC and CAPA investigation reports, change records, certificates of analysis
  • Support customer complaint investigations
  • Perform quality reviews for calibration and validation to ensure compliance
  • Prepare and analyse routine QMS metrics and reporting for the business
  • Support quarterly and annual management reviews
  • Lead improvement projects to completion that may be initiated from NC, CAPA, internal audits, and site or department goals
  • Support external audits and supplier audits
  • Occasional activities will include supporting training management, internal audit and document control activities in our drive for continual improvement

Who we're looking for

  • You have a BSc (Hons)/MSc or higher degree in biochemistry, molecular biology, or a closely related discipline
years quality experience (NC, CAPA, root cause investigations, internal and external audit) with molecular biology product (or similar) manufacturing, support, and/or product development

  • You have demonstrated excellence in both written and verbal communication
  • You have very strong interpersonal skills and an ability to work as an effective member of crossfunctional teams
  • You are able to work independently with responsibilities and stakeholders across multiple global sites
  • You can think on your feet and address problems as they arise with a solutions focussed outlook
  • You have outstanding attention to detail and excellent organisational skills
  • You have the ability to multitask, perform consistently under pressure and work without supervision
  • You have a growth mindset, are open to feedback and are willing to continue to learn and grow your knowledge, skill set and personal leadership capacity
  • You are committed to product quality with a high level of self motivation
  • You are able to have fun and thrive in a growing, agile, diverse and inclusive work environment

Additional preferred knowledge and experience

  • ISO 13485, ISO 9001, or cGMP industry experience
  • Experience supporting or participating in internal and external audits
  • Experience with equipment and processes involved in the manufacturing of genomics reagents or medical devices
  • If you do not match all the criteria listed above but feel that you may be able to contribute scientifically to the organisation with other aligned complementary skill sets, we encourage you to still consider applying. As a growing organisation committed to excellence, we are passionate about finding the right individual and upskilling where required._

Application Procedure

  • Letter of motivation
  • Resume or _Curriculum vitae_, highlighting relevant qualifications and experience


If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.

- **_
-
WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER_

  • Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law._

Job Types:
Full-time, Permanent


Application Question(s):

  • If one of your colleagues approached you for support with a product QC failure, what steps would you take to investigate and provide product disposition?
  • If you are walking through the Production facility, and you notice a colleague not following a procedure, what would you do?
  • How would you approach responding to an audit finding? What would you do differently for a major versus a minor finding?
More jobs from Watchmaker Genomics
See all jobs of Watchmaker Genomics