QA Specialist II (Validations)
PCI Services2d ago
This role ensures compliance with GMP standards within pharmaceutical operations. You will manage equipment qualification, process validation, and quality documentation.
LeónFluent Spanish
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91,000+ live jobsQC Microbiological I
On-site in León·Full-time·Added 2 months ago (last checked 23 Oct)
PCI Services
13 open roles
Our summary
- Work mode
- On-site, León
- Contract
- Full-time
Visa options
The ad doesn’t mention sponsorship
Not a refusal, but not a yes. Worth asking in your first message.
Skills
This job advert was originally written in Spanish.
The role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
What you'll do
- Perform duties following quality criteria and health and safety standards.
- Perform the functions of the position attending to the behavioral Values established by the company.
- Work in accordance with GMP regulations.
- Report the work performed to the Microbiological Quality Control Manager / Technician.
- Documentary work:
- Detection of possible out of specification (OOS) results, out of trend (OOT) results, and deviations. Collaboration in investigations.
- Documenting executed activities following GMP standards and LSNE-León work procedures.
- Laboratory work
- Execution of microbiological assays and performance of analyses according to established internal methods and procedures. Interpretation of results.
- Execution of environmental and personnel controls in the application areas.
- Organization and execution of gowning qualifications for entry into classified rooms.
- Perform microbiological sampling and analysis of raw materials, bulk product, intermediate product, final product, and packaging materials.
- Perform control of calibration, verification, and maintenance of analytical equipment.
- Interpretation and execution of applicable GMP documentation at the microbiological quality control laboratory.
- Management and control of samples.
- Control of materials, reagents, reference strains, culture media, etc., used in the microbiological development laboratory and communication of needs to the technician/manager.
- Organization and cleaning of the laboratory rooms.
About PCI Services
In their own words
About the company & team
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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