Quality Assurance Engineer II
JenzabarSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
Candidates should possess knowledge and experience in Quality Systems and/or Operational Quality, including Deviation/Change Control, Laboratory Investigations, and Environmental Monitoring. Strong understanding of cGMP and regulatory requirements is essential, along with experience using Trackwise. Fluency in English, both orally and in writing, is required, and the ability to travel internationally, specifically to Italy and abroad, is necessary.
Responsibilities
The QA/Validation Engineer will prepare Batch Dispositions, conduct Batch record reviews, oversee the certification process, support all quality and compliance requirements for commercial manufacturing, and improve Quality Systems and Operational Quality with clients. They will also solve complex problems, provide guidance and support for continuous improvement, interpret client needs, assess requirements, identify solutions to non-standard requests, and ensure the highest Quality, Compliance, and Safety standards while collaborating to facilitate client alignment and best practices.
Skills
cGMP
Trackwise
Deviation Control
Change Control
Laboratory Investigations
Environmental Monitoring
Batch Disposition
Batch Record Review
Certification Oversight
CAI
Consulting for operational readiness in healthcare
About CAI
CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.
Overland Park, KansasHeadquarters
1996Year Founded
$3.4MTotal Funding
PRE_SEEDCompany Stage
Industrial & Manufacturing, Biotechnology, HealthcareIndustries
1-10Employees
Benefits
100% Employee Owned
24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
Professional Development (Approximately $5,000 paid career-related, continuing education)
ESOP/401k – 15% Company Contribution
Company Paid Long-Term Disability
Company Paid Life Insurance
Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
Other Benefits Depending on Country
Risks
Competition from specialized firms in digital transformation may erode CAI's market share.
In-house consulting teams in corporations could reduce demand for CAI's services.
Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.
Differentiation
CAI offers comprehensive consulting services across multiple industries, including life sciences.
Their expertise in energy management aligns with the sustainability focus of data centers.
CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.
Upsides
Demand for digital transformation in life sciences boosts CAI's automation consulting services.
Personalized medicine trends create opportunities for flexible manufacturing process consulting.
Data centers' focus on energy efficiency aligns with CAI's energy management expertise.
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