Alkermes, Inc.
Sr QA Associate I - Laboratory Support
Alkermes, Inc., Wilmington, Ohio, United States, 45177
The Quality Assurance Senior Associate – Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratories.
MAJOR RESPONSIBILITIES
Act as QA Lab Support representative on special committees and teams.
Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements. Actively participate and contribute to the QA mission and objectives. Deliver key business messages to superiors and/or peers in a timely manner. Develop metrics and other tools to measure QA Lab Support and/or systems. Understand departmental KPIs and their impact on site targets.
(30%)
Interact with laboratory personnel to ensure cGMP compliance.
Provide general guidance and support, acting as an ambassador of quality and compliance, driving quality culture by actively mentoring or coaching within the QA and laboratory organizations.
(20%)
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.
(20%)
Review, approve, and oversee the change control process.
Manage minor change controls generated by the laboratory, including amendments and extensions.
(15%)
Act as the QA Contact and QA Approver for laboratory investigations.
Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place. Lead exercises in root causes analysis for complex issues. Act as an internal auditor, leading audits when necessary.
(15%)
QUALIFICATIONS
Capable of identifying solutions and following through to implementation.
Excellent communication and documentation skills.
Experience providing feedback on deficiencies to improve systems, procedures, and training.
Possesses the skills necessary to provide effective training/mentorship.
Familiarity with standard Chemistry and/or Microbiology laboratory techniques.
Good understanding of current quality control and quality assurance GMP regulations.
Continues to develop knowledge in relevant suite of products or analytical techniques.
Possesses the drive to achieve results and proactively seeks solutions.
Demonstrates ability to generate and critique high quality/quantity of results.
Appreciates the organizational vision/site strategy.
Displays the appropriate amount of energy and concentration to "stay with the job."
Years of Experience
Bachelor's in Chemistry or Biology (or related field) with 5+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or, Master's in Chemistry or Biology (or related field) with 4+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience.
Working Environment/Physical Demands
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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#LI-RS1
#Hybrid
#J-18808-Ljbffr
MAJOR RESPONSIBILITIES
Act as QA Lab Support representative on special committees and teams.
Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements. Actively participate and contribute to the QA mission and objectives. Deliver key business messages to superiors and/or peers in a timely manner. Develop metrics and other tools to measure QA Lab Support and/or systems. Understand departmental KPIs and their impact on site targets.
(30%)
Interact with laboratory personnel to ensure cGMP compliance.
Provide general guidance and support, acting as an ambassador of quality and compliance, driving quality culture by actively mentoring or coaching within the QA and laboratory organizations.
(20%)
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.
(20%)
Review, approve, and oversee the change control process.
Manage minor change controls generated by the laboratory, including amendments and extensions.
(15%)
Act as the QA Contact and QA Approver for laboratory investigations.
Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place. Lead exercises in root causes analysis for complex issues. Act as an internal auditor, leading audits when necessary.
(15%)
QUALIFICATIONS
Capable of identifying solutions and following through to implementation.
Excellent communication and documentation skills.
Experience providing feedback on deficiencies to improve systems, procedures, and training.
Possesses the skills necessary to provide effective training/mentorship.
Familiarity with standard Chemistry and/or Microbiology laboratory techniques.
Good understanding of current quality control and quality assurance GMP regulations.
Continues to develop knowledge in relevant suite of products or analytical techniques.
Possesses the drive to achieve results and proactively seeks solutions.
Demonstrates ability to generate and critique high quality/quantity of results.
Appreciates the organizational vision/site strategy.
Displays the appropriate amount of energy and concentration to "stay with the job."
Years of Experience
Bachelor's in Chemistry or Biology (or related field) with 5+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or, Master's in Chemistry or Biology (or related field) with 4+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience.
Working Environment/Physical Demands
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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#LI-RS1
#Hybrid
#J-18808-Ljbffr