The Quality Control Compliance Specialist is responsible for monitoring compliance of the Quality Control Department.
| Major Responsibilities | Percentage of time spent on each responsibility |
| Contribute to the compliant operation of the QC Stability Program including but not limited to attending project meetings as the QC Compliance Team representative; drafting, reviewing, and approving stability protocols and reports; initiating stability studies, performing stability pulls, and data trending. Assist with drafting, review, and approval of CMC sections of regulatory documents. Assist with investigation of product complaints and adverse events. Maintain up-to-date stability data systems. | 25% |
| Perform timely data review of data generated during laboratory operations to ensure compliance with applicable regulations and internal procedures. Review and approve data packages for submission to QA for final disposition. | 25% |
| Provide consultation on quality and compliance topics in areas of expertise and assist with quality improvement initiatives. Revise systems and processes and implement associated controlled documentation. Originate action to improve performance within the laboratory using appropriate methods to identify opportunities and implement solutions. Identify discrepancies, execute investigations and implement associated CAPA. Lead Root Cause Analysis exercises within the department for complex issues. | 20% |
| Write, revise, review, or approve SOPs, analytical protocols, analysis reports, specifications, and controlled forms. Review and approve technical reports and protocols originating in other departments. | 15% |
| Provide training and support to the Quality Control group. Ensure staff is adequately trained to perform job assignments. Execute training in accordance with written procedure including but not limited to performing training assessments, documentation of training, and assisting in the preparation of training programs and curricula. | 10% |
| Act as QC Compliance and/or Quality Control 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 Laboratory Services mission and objectives. Deliver key business messages to superiors and/or peers in a timely manner. Develop metrics and other tools to measure QC Compliance and/or systems. Understand departmental KPIs and their impact on site targets. Act as an ambassador of QC Compliance by actively mentoring or coaching within the QC Organization. | 5% |
- Capable of identifying solutions and following through to implementation. Has the capacity to monitor the effectiveness of system and process changes and continuously improve.
- Excellent communication and documentation skills. Facilitates dialogue and values input from others. Communicates well in team settings. Seeks to understand others with diverse view points and expertise. Builds strong relationships with stakeholders external to the laboratory.
- Experience providing feedback on deficiencies to improve systems, procedures and training. Demonstrates diplomacy and tact to diffuse tense situations and presents facts to support decision/point of view.
- Possesses the skills necessary to provide effective training/mentorship.
- Familiarity with standard laboratory techniques such as water content determination, dissolution, HPLC, GC, infrared spectroscopy, DSC, UV, particle size, and Microbiology assays.
- Possesses a good understanding of current quality control GMP regulations.
- Continues to develop knowledge in relevant suite of products or analytical techniques and expands breadth of knowledge to include areas outside of direct function.
- Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging, taking action to overcome likely obstacles.
- Demonstrates ability to present information coherently to an internal and/or external audience.
- Appreciates the organizational vision/ site strategy and understands how team and individual objectives are aligned.
- Displays the appropriate amount of energy and concentration to "stay with the job" and displays the versatility to accommodate changes that might be required to the schedule to ensure all work activities are completed as required.
- Recognizes and displays many of the hallmarks of a personally productive individual. Invests upfront in an appropriate amount of preparation for the task in hand, can eliminate the time-wasting activities, takes an ordered approach to execution.
EDUCATION AND EXPERIENCE
- QC Compliance Specialist II: Bachelors in Chemistry or Biology (or related field) with 4+ years of cGMP laboratory experience; or,
- QC Compliance Specialist III: Bachelors in Chemistry or Biology (or related field) with 6+ years of cGMP laboratory experience; or,
- QC Compliance Specialist IV: Bachelors in Chemistry or Biology (or related field) with 8+ years of cGMP laboratory experience
Masters in Chemistry or Biology (or related field) with 5 years of cGMP laboratory and/or Pharmaceutical Quality experience; or, PhD in Chemistry or Biology (or related field) with 4 years of cGMP laboratory and/or Pharmaceutical Quality experience
WORKING CONDITIONS
- Office environment
- Occasional work in cold temperature environmental chambers
PHYSICAL REQUIREMENTS
- Prolonged periods of sitting or standing
- Occasional periods of repetitive motion
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About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.