Sr. QA Associate I at Alkermes, Inc. in Wilmington, Ohio

Job Description:

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Sr. QA Associate I

Positions Summary:

The Senior Quality Assurance Associate - Laboratory Support, is responsible for supporting daily operations and monitoring compliance of the laboratories.

Major Responsibilities:

• Represent QA Lab Support in operational meetings and project teams. Lead specific aspects of a project and guide solutions for difficult problems. Actively participate and contribute to the QA mission and objectives. Deliver key business messages to superiors and/or peers in a timely manner. Develop and maintain metrics to measure the performance of QA Lab Support and/or systems.


• Act as the QA Contact and QA Approver for laboratory investigations, CAPA and other QA Functions as defined in QA Roles & Responsibilities. Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place. Lead root cause analysis within areas of support or cross-functionally for complex issues. Act as an internal auditor, leading audits when necessary.


• Review, approve, and oversee the change control process for minor and major change controls generated by the laboratory, including amendments and extensions.


• Interact with laboratory personnel to ensure cGMP compliance and provide general guidance and support. In these interactions, act as an ambassador of quality and compliance, driving quality culture by actively mentoring or coaching within the QA and laboratory organizations.


• Review and approve SOPs, analytical protocols, test methods, training plans, work orders, and controlled forms. Provide input for, review, and approve technical protocols and reports, stability protocols and reports, and instrument qualification documents authored by the laboratories.

Required Education and Experience:

Masters in Chemistry or Biology (or related field) with 4 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or

BS/BA in science related field supplemented with 6 years additional experience in pharmaceutical environment; or

AS in science related field supplemented with 8 years additional experience in pharmaceutical environment.

Preferred Competencies and Behaviors:

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  Leadership:

  
  
  
  
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    Listens to others and values opinions, promotes a team atmosphere. Anticipates and resolves conflict. Defines processes and goals, works for consensus.

    
    
  
  
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    Serves as a mentor and role-model for associates.

    
    
  
  
  
  

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  Productivity

  
  
  
  
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    Meets team deadlines and responsibilities.

    
    
  
  
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    Develops realistic plans, sets goals, plans for and manages resources, creates contingency plans, coordinates/cooperates with others

    
    
  
  
  
  

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  Communication:

  
  
  
  
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    Competent technical writer. Can compile complex technical information into clear, concise, documents appropriate for the target audience.

    
    
  
  
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    Competent presenter. Able to lead meetings and confidently present information to peers and leaders.

    
    
  
  
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    Demonstrate empathy and active listening; provide opportunities for open discussion with employees and customers.

    
    
  
  
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    Build strong relationships with stakeholders, work to understand alternate viewpoints. Leverage these relationships to identify improvement opportunities.

    
    
  
  
  
  

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  Problem Solving:

  
  
  
  
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    Demonstrate excellent critical thinking skills. Able to analyze data, identify patterns/trends. Can make risk-based decisions, supported by facts and aligned with current guidance and regulations.

    
    
  
  
  
  

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  Continuous Improvement:

  
  
  
  
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    Provide feedback on deficiencies to improve systems, procedures, and training. Capable of identifying solutions and following through to implementation.

    
    
  
  
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    Demonstrate diplomacy and tact when managing change, present facts to support decisions/point of view.

    
    
  
  
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    Can monitor the effectiveness of system and process changes and continuously improve.

    
    
  
  
  
  

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  Technical Expertise:

  
  
  
  
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    Familiar with common Chemistry and/or Microbiology laboratory techniques such as: water content determination, dissolution, HPLC, GC, infrared spectroscopy, DSC, UV, particle size, bioburden, environmental monitoring, endotoxin, and sterility.

    
    
  
  
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    Possess a good understanding of current Quality Control and Quality Assurance GMP regulations.

    
    
  
  
  
  

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  Personal Development:

  
  
  
  
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    Set personal development goals based on career aspirations and interest.

    
    
  
  
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    Continue to develop knowledge in relevant pharmaceutical regulatory requirements and guidance.

    
    
  
  
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    Develop/maintain knowledge of Alkermes products and analytical techniques. Expand knowledge to include areas outside of direct function.

    
    
  
  
  
  

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

#LI-DB1

Experience Level:
Associate

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