Alkermes

Senior Quality Assurance Associate II

Alkermes • $90K — $110K *
Wilmington, OH 45177In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 6+ years of experience in a pharmaceutical quality function
  • Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
  • QA Experience in pharmaceutical product development, especially for early phase clinical trials
  • Broad quality experience, including manufacturing operations and drug product release
  • Strong troubleshooting and problem-solving skills
  • Proficiency in risk assessment tools
  • Effective planning, organizing, and prioritizing of work

Responsibilities

  • Interface with contract manufacturing organizations to ensure compliance with Alkermes Quality policies and cGMPs
  • Facilitate review and release processes with the QP
  • Maintain and enhance quality systems for regulatory compliance
  • Represent the department in cross-site projects
  • Monitor quality indicators to identify trends and risks
  • Lead or support investigations into quality issues and ensure corrective actions are implemented
  • Promote Good Manufacturing Practices (GMPs) in all activities
  • Provide quality assurance guidance to development teams for various operations
  • Evaluate quality and technical issues related to product development
  • Mentor QA Associates and provide performance feedback

Benefits

  • Health and wellness programs
  • Professional development opportunities
  • Flexible work arrangements
  • Collaborative work environment
  • Performance recognition programs
Full Job Description
Responsibilities

Responsibilities:
  • Primary interface with contract manufacturing organizations including oversight of ongoing CMO activities vs. Alkermes Quality policies and cGMPs. Oversight responsibilities include review of batch documentation, deviations, investigations, and change controls
  • Facilitate and interact with QP for review and release process
  • Maintenance and enhancement of quality systems to ensure conformance to Alkermes quality practices and international regulatory compliance requirements
  • Represent department on cross site projects
  • Monitor quality indicators highlighting trends and risks
  • Independently lead and/or support investigations into variances and quality issues and able to assure that proper changes are made to guarantee continued and consistent product quality
  • Proactively promote GMPs
  • Provide quality assurance representation, guidance, leadership, and direction to product development teams for two or more different operations which include; API/drug substance, drug product and labeling/packaging operations
  • Identify and evaluate quality, technical and product development issues
  • Provide guidance/mentoring to QA Associates and cross functionally and provide performance feedback to CMO as appropriate
  • Review of regulatory documentation and submissions


Qualifications

Skills / Qualifications
  • 6+ years of experience in a pharmaceutical quality function
  • Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
  • QA Experience in pharmaceutical product development and expectations for early phase clinical trials
  • Broad quality experience, preferably including manufacturing operations, API and drug product release, method development, method validation and transfer, QP release, process validation.
  • Strong ability to troubleshoot and problem solve
  • Demonstrated proficiency in use of risk assessment tools
  • Ability to effectively plan, organize and prioritize work


Education
  • Bachelor's degree in a scientific discipline or related field

#LI-RS1

#LI-Onsite

About Alkermes

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. Alkermes was founded in 1987 and has approximately 2,000 employees.
Learn more about Alkermes
Size
2,211 employees
Market Cap
$4.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
-$110.8 million
Founded
2011
5 Year Trend
+9.5%
Revenue
$1 billion
NASDAQ
ALKS
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Alkermes

More Pharmaceuticals & Biotech Jobs

Find similar Senior Quality Assurance Associate II jobs:

NationwideWilmington, OH