Amgen

Mgr Quality Control

Employer
Amgen
Location
Juncos, PR, US
Posted
Jun 25, 2019
Ref
R-78376
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY

This position will be responsible for leading the Micro ID Laboratories (ID, QPCR, Growth and Fermentation) within the Microbiology Laboratories Unit. Supervision of direct reports, development of staff, leading project teams, and monitoring GMP compliance of function.

SPECIFIC RESPONSBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Leads the Micro ID, (ID, QPCR, Growth and Fermentation) operations, using Lean and Operational Excellence tools.
  • Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results.
  • Primary point of contact for evaluation of compendia changes impact to the site.
  • Responsible for coaching, counseling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
  • Assist the QC Department Director in the translation of strategy and mission into the QC laboratory department goals.
  • Maintains laboratory quality service by enforcing quality and customer service standards.
  • Analyzes and resolves laboratory issues, establishes robust CAPA's.
  • Maximize performance by introducing processes and procedures; partner with departments to drive changes.
  • Foster a positive working environment of partnership, transparency, and teamwork throughout the Department and organization.
  • In depth knowledge of QC Laboratory working principles, Good Documentation and Laboratory Practices (GDP and GLP).
  • Translate organizations strategy and mission into meaningful department goals.
  • Maximize performance by introducing processes and procedures; partner with departments to drive changes.
  • Develop training curriculum for department.
  • Assess laboratory capacity, strategize, and deliver results on time.
  • Coordinates and plans detailed laboratory work plans/schedules.
  • Identifies opportunities and drive initiatives to reduce error, gain laboratory efficiency, and reduce cycle time.
  • Creates and maintains robust laboratory processes.
  • Understands, uses, and executes in laboratory electronic systems and Quality systems.


EDUCATION/LICENSES

Doctorate degree

OR

Master's degree in Life Sciences & 3 years of experience in pharmaceutical, medical devices or biotechnology industry
OR

Bachelor's degree in Life Sciences & 5 years of experience in pharmaceutical, medical devices or biotechnology industry

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

PREFERRED QUALIFICATIONS
  • Educational background preferably in Life Sciences (Microbiology or Mycology)
  • Strong leadership skills
  • Thorough knowledge in the use and application of USP, EP and JP Pharmacopeias.
  • Thorough knowledge of biological products and solid dosage forms.
  • Ability to delegate wisely and effectively.
  • Hands on experience in an Operational Excellence laboratory working environment. Knowledgeable in Operational Excellence tools.
  • Works effectively with diverse departmental groups.
  • Excellent team development and leadership skills.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, Quality Assurance, Quality Control, Validation, and Process Development.
  • Basic knowledge in Molecular Biology principles, such as PCR and DNA Sequencing.
  • Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply.
  • Able to make sound, quality decisions independently.
  • Excellent communication (both written and verbal), facilitation, and presentation skills. Both English and Spanish.
  • Skilled in risk management.
  • Demonstrate the Amgen Values/Leadership Attributes


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.