QC Technician in Livermore, CA at Apex Life Sciences

Date Posted: 9/15/2018

Job Snapshot

Job Description


Quality Control Technician

The following is a list of essential duties and responsibilities for this position along with certain supportive duties. This list is not all-inclusive. This position requires attention to detail, strong problem identification/analysis skills and ability to interaction with all departments internally.

Job Responsibilities:

  • Provide Quality support to Manufacturing (Bulk & Assembly production)
  • Testing of incoming Raw Materials & finished products.
  • Understanding and adherence to applicable regulatory authority and guidelines.
  • Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
  • Maintain and manage controlled documents.
  • Experience in training employees.
  • Record keeping/documentation of analysis
  • Review contract lab data for accuracy
  • Monitor QC lab supplies
  • Maintain accurate and current Quality records
  • Assist with investigations for customer’s complaints and NCMR.
  • Hands on experience with Risk Assessment.
  • Functional understanding of the FDA Drug Development Cycle.
  • Demonstrated ability to understand and relay/incorporate expertise given from technical team.
  • Perform other responsibilities as assigned

Qualifications:

  • Science degree or related scientific background
  • 0-3 years Quality experience

Skills:

  • Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
  • Knowledge of basic chemistry & microbiology laboratory techniques is preferable.
  • Proficient computer skills, (MS Word, MS Excel are essential).
  • Strong attention to detail
  • Understand and independently apply GMPs to everyday work with regard to documentation and review.
  • Understanding and adherence to applicable regulatory authority and guidelines.
  • Demonstrates theoretical understanding of the work tasks assigned.
  • Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
  • Ability to learn, retain, and apply technical information on multiple topics.
  • Develop and execute complex procedures with high quality.
  • Understanding of pharmaceutical laboratory and / or production operations.
  • Ability to complete investigation, deviation, and change control forms independently.
  • Author, edit and review Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports.
  • Ability to problem solve to initiate and execute/monitor corrective action.
  • Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
  • Mathematical and scientific reasoning ability.
  • Familiar with quality risk management, regulations and their context.
  • Good working knowledge of quality systems and risk management.
  • Can effectively back-up supervisor to address limited technical or business issues with prior instructions. Strong problem identification/analysis and solving skills with hands-on approach in resolving issues
  • Excellent verbal and written communication skills
  • Strong sense of accountability, responsibility, and ownership of projects and tasks
  • Exhibit a professional standard and strong work ethic
  • Excellent organizational skills and time management skills
  • Ability to multi-task and prioritize in a fast-paced environment
  • Ability to interface with all personnel levels within the company
  • Motivated self-starter with ability to work independently on multiple assignments in a team environment.
  • Consistent performance with a sense of urgency and commitment

email: dgilbrech@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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