Associate Quality Control
Amgen - Municipio de Juncos, PR

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SUMMARY
Under general supervision, responsible for one or more of the following activities in Quality Control including analytical testing, characterization, method development, and sample and data management

FUNCTIONS
1. Perform routine laboratory procedures*
2. May perform aseptic aliquot ting, sampling and analysis for compendia and non-compendia methods*
3. May perform non-routine lab procedures under close supervision*
4. Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance*
5. Prepare complete, accurate, concise laboratory documentation*
6. Data entry, review, analysis and communication of results*
7. Perform general lab housekeeping
8. Maintain/operate specialized equipment*
9. Participate in the document revision process
10. Comply with safety guidelines, cGMPs and other applicable regulatory requirements*
11. May participate in lab investigations/ audits
12. Maintain training proficiency*
13. May approve lab results

** Other functions may be assigned

Knowledge:
1. Knowledge of basic principles, methods and practices of technical/ scientific field
2. Typically obtained through formal study
3. General knowledge of procedures and activities within own work area
4. Ability to relate day-to-day work to business priorities
5. General understanding of industry practice and standards

Problem Solving:
1. Applies broad-based research, information gathering and analytical skills to factual information
2. Selects appropriate alternatives from defined options
3. Collects required documentation/raw data; verifies conformance of documents
4. Assesses accuracy of detailed information
5. Tracks, maintains and produces regular work products
6. Ability to identify roadblocks to task completion and effectively brings them to line managers for resolution

Autonomy:
1. Works under general direction, seeks assistance as needed
2. Completes work in accordance with established procedures and practices within field of technical/scientific knowledge
3. Establishes approaches for completing assignments
4. Work requires consistent exercise of discretion and independent judgment
5. Works with team to support achievement of project milestones

Contribution:
1. Contributes to own work group/team through quality and accuracy of own output
2. Builds productive internal/external relationships Basic Qualifications EDUCATION/LICENSES
Bachelor’s degree Preferred Qualifications COMPETENCIES/SKILLS
  • Ability to understand, apply, and evaluate basic chemistry, biology, physical principles and mathematics
  • Ability to adhere to regulatory requirements, written procedures and safety guidelines
  • Ability to evaluate documentation/data according to company and regulatory guidelines
  • Ability to organize work, handle multiple priorities and meet deadlines
  • Demonstrated written and oral communication skills
  • Technical writing capabilities
  • Presentation capabilities
  • Must be detail oriented
  • Must be flexible and adaptable to changing priorities and requirements
  • General understanding of Amgen products and QAL operations
  • Ability to interact with inspectors (internal and external)
OTHER PREFERRED QUALIFICATIONS
Bachelor in Natural Science
Minimum 2 years industry experience preferably in Aseptic techniques, Environmental Monitoring, and Media Fill.

Amgen - 22 months ago - save job - block
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Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...