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Quality Control Analyst
hace 6 días
**Purpose**:
The Affiliate QC Analyst of the Chemical Laboratory is responsible for performing laboratory testing
within a GMP environment in support of finished product local import testing requirements. Use of
scientific education to perform laboratory testing within a good manufacturing practices environment
to generate results and interpretation of the data output to determine conformance. Experienced and
demonstrated command of multiple laboratory techniques to perform testing with mínimal error and
implementation of new technologies or processes. Understanding of internal business process to
determine appropriate prioritization of assigned work duties. This position will ensure that all local
import testing related quality activities are compliant with Corporate, governmental, local regulations
and requirements and prioritized based on business needs.
**Responsibilities**:
- Analysis of finished products.
- Analysis of stability samples according to current methods.
- Analysis of printed materials.
- Participate in test method transferences for new methods/new products. Perform analytical test
methods as written and perform data verification of laboratory results to support product release
without error.
- GMP: Comply with cGMP and GLP. Participate in activities derived from regulatory authorities
requirements.
- Assist with integration and support of quality regulations. Assist in the design of effective
Laboratory Control Quality System, procedures and/or process within cross functional teams to
ensure compliance as well as efficiency.
- Understand laboratory techniques and principles performed and can independently troubleshoot
and resolve analytical techniques and instrument issues. Implement and ensure improvement
ideas are completed to facilitate team objectives.
- Ability to work in multiple laboratory functional areas as assigned and can effectively perform a
multitude of laboratory techniques for which trained on with mínimal error while adjusting to
unforeseen technical or logístical obstacles to accomplish assignments.
- Budget time effectively to complete assigned tasks and make recommendations for improvement.
Take initiative to be involved in team activities and decision making.
- Maintain training requirements and certifications as needed for assigned job tasks and take
responsibility to add new training diversification to meet broader team objectives.
- Perform assessments to determine compliance to processes, procedures and regulations to identify
potential gaps and mitigate and implement improvements. Support internal and external quality
inspections and audits.
- Represent affiliate QC in regional, global and cross functional teams, projects and programs, as
assigned by management.
- Assure the minimum stock of reagents, materials, etc.
**Qualifications**:
- Advanced Student or Bachelor’s Degree in Pharmacy, Biochemistry or equivalent science degree.
- 2+ years’ of laboratory experience.
- Ability to work with general supervision with effective management of own time to multi task based upon training matrix.
- Demonstrated strong analytical skills and logical thought process.
- Knowledge of applicable regulations, quality systems and principles of quality assurance.
- Knowledge and familiarity with product, process, and both internal and external customer requirements.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
- Demonstrated strong laboratory skills and abilities.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills and problem-solving skills.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro and various laboratory systems.
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