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Alkermes

QC Specialist III/IV

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GENERAL DESCRIPTION:

The Quality Control QC SPECIALIST III/IV is responsible for lifecycle management, compliance, and performance of analytical instrumentation used within Quality Control laboratories. This role serves as a technical expert, ensuring instrument qualification, calibration, maintenance, troubleshooting, and data integrity meet regulatory expectations (FDA, ICH, JP).

MAJOR RESPONSIBILITIES

Instrumentation Management

  • Oversee lifecycle management of chemistry or microbiology laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, or TOCs, Particle Counters, MAS-100 Viable Air Sampler, respectively, and other analytical platforms

  • Lead installation, qualification, and validation (IQ/OQ/PQ) activities in compliance with regulatory guidelines

  • Ensure instruments remain in a validated state through periodic calibration, preventive maintenance, and requalification activities

  • Manage instrument asset tracking systems and documentation.

Compliance & Data Integrity

  • Support Risk assessments to ensure all instrumentation, software, and data systems comply with Alkermes, data governance policy and data integrity principles (ICH Q9)

  • Develop, review, and approve SOPs, protocols, and reports related to instrumentation.

  • Support internal audits, client audits, and regulatory inspections

  • Support Investigations, deviations, out-of-specification (OOS), and out-of-trend (OOT) results associated with instrumentation

Technical Expertise & Troubleshooting

  • May serve as SME or support the SME for complex instrument troubleshooting, root cause analysis, and resolution of technical issues

  • Coordinate with vendors for instrument repairs, upgrades, and service contracts

  • Support the evaluation and implementation of new technologies, software, and analytical tools.

  • Support method transfers from an instrument qualification perspective

Project Leadership

  • Lead or support cross-functional projects such as lab expansions, new equipment implementation, and digital transformation initiatives

  • Drive continuous improvement initiatives to enhance lab efficiency, reliability, and compliance.

  • Manage change control processes related to instrumentation and systems

Documentation & Systems Management

  • Maintain accurate and complete records for calibration, maintenance, qualification, and deviations

  • Oversee computerized systems validation (CSV) for laboratory instruments and software platforms

  • Support other groups to ensure proper configuration and compliance of laboratory data systems (e.g., Empower, LIMS).

Training & Mentorship

  • Train and mentor other QC specialists on instrument operation, troubleshooting, and compliance requirements

  • May train and mentor QC analysts, as requested

  • Serve as a resource for best practices in laboratory instrumentation

SKILLS/COMPETENCIES

  • Deep knowledge of instrument qualification and validation (IQ/OQ/PQ)

  • Strong understanding of data integrity and compliance regulations

  • Excellent troubleshooting and root cause analysis skills

  • Experience with laboratory software (e.g., Empower, LIMS, CDS systems)

  • Experience with Maximo

  • Strong documentation and technical writing abilities

  • Project management and leadership capability

  • Effective communication and cross-functional collaboration

PERSONAL ATTRIBUTES

  • Ability to work hard and contribute to an enjoyable rapidly changing working environment

  • Proactively achieves results for the best of the organization

  • Willingness to learn new things

  • Commitment to teamwork

  • Commitment to continuous improvement in all areas

  • Ability to focus attention to details and ensure high quality work

  • Ability to work safely; seek out and encourage safe practices

  • Takes input from others and stimulates open discussions

  • Excellent communication and documentation skills

EDUCATION/EXPERIENCE:

QC SPECIALIST III

  • Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or

  • Masters Degree in Chemistry with approx. 2 years of laboratory experience

QC SPECIALIST IV

  • Bachelors Degree in Chemistry with approx. 5 years of laboratory experience or

  • Masters Degree in Chemistry with approx. 3 years of laboratory experience

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