Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Mission CriticalIndustries
Requirements
- Provides knowledge and experience in Quality Systems and/or Operational Quality (e.g., Deviation/Change Control/Investigations/Environmental Monitoring), mainly focused on Equipment Qualification
- Strong cGMP and regulatory requirement understanding
- Support all quality and compliance requirements for and leading to commercial manufacturing
- Expertise in Microsoft Word and Excel
- Excellent oral and written English
- Available for working travel
- Creates strategies to balance short-term requirements with long-range business plans
- Pursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats
- Aligns strategic priorities of own area with current direction and strategic priorities of the broader organization
- Demonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results
- Promotes best-in-class risk awareness and reviews risk management performance on a continuing basis
- Draws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic opportunities
Responsibilities
- Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement
- Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests
- Ensure the highest Quality, Compliance and Safety standards
- Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality
- Deliver Business Growth Strategies
Skills
Quality Assurance
QA Testing
Operational Readiness
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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