Job Description

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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