Quality Control Analyst - Buenos Aires, Argentina - ABBVIE

ABBVIE

Empresa verificada

Buenos Aires, Argentina

hace 1 semana

Publicado por:

Sofía Rodríguez

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Descripción

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 problemsolving skills.
Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro and various laboratory systems.