QC Validation Specialist (323237)
As an ASAT/QC Validation Specialist, you will manage non-testing Lab Support systems and processes for QC, including: Equipment Initial Purchase and Qualification as well as implementation of Lifecycle and Preventative Maintenance.
Execute non-routine, non-testing tasks within QC, including change controls to qualify new equipment. You will work collaboratively with local QC equipment owners to establish effective audit trails for complex equipment and serve as the QC SME for automation and validation as related to QC equipment.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Drive a strong safety culture within QC and the site. Adhere to established EHS policies and procedures.
Equipment Change Control author/coordinator
Decommissioning of obsolete equipment
Author required validation documents (including but not limited to VWP, URS, IOQ, VSR, PQ, etc.)
Serve as Project Manager for procurement of lab equipment.
Data Integrity and equipment audit trail lead and technical expert.
Benchmark with GSK sites and regulatory requirements to ensure equipment is in alignment within the network and regulatory expectations.
Ensure work orders (Cal/PM/Audit trail) are implemented effectively during equipment qualification process
We are looking for professionals with these required skills to achieve our goals:
B.S or B.A in Microbiology, Biochemistry, or a related scientific discipline
3+ years experience in a cGMP-regulated environment
1+ years experience in validation, calibration, or laboratory equipment/instrument maintenance
If you have the following characteristics, it would be a plus:
Experience with lean manufacturing tools and statistics. Green belt certification preferred.
Experience with pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
Experience with GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
Experience with communicating both verbally and in writing with all levels both inside and outside of the organization.
Experience with clearly writing technical documentation as necessitated by regulatory agencies and internal policy.
Experience with establishing and maintaining working relationships with staff and the ability to analyze data and implement changes.
Experience with addressing complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
Aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
Participate in cross-functional deviations as needed.
Strong technical writing skills. Strong technical writing skills.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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