Analytical Services Scientist

Avara Pharmaceutical Services; Arecibo (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Avara Pharmaceutical Services is seeking an Analytical Technology lead to support Quality Control during new product introductions. The role covers method development, validation, transfer and instrument service, ensuring QC systems comply with FDA/cGMP and GAMP standards.

The incumbent will collaborate across departments, manage validation documentation, and guide improvements to laboratory processes and electronic systems.

Qualifications

• Bachelor's degree in science, engineering or computer science from an accredited institution.
• At least five (5) years of laboratory experience or systems validation in an FDA regulated environment.
• CSQE certification preferred.
• Chemical Licensee preferred.

Responsibilities

• Collaborate with functional areas to determine regulatory requirements and validation deliverables.
• Generate, review and approve validation/automation documentation and SOPs.
• Coordinate validation of laboratory equipment, facilities, utilities and software per FDA, cGMP and GAMP guidelines.
• Perform method development, validation, transfer and verification for products.
• Support CAPA, change control and incident resolution to improve laboratory processes.

Skills

Regulatory compliance

Project management

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in Science/Engineering/CS

Tools

LIMS Vantage

LIMS Lab Ware

CDMS Empower

HPLC

UPLC

GC

FTIR

NIR

Dissolution Bath

KF

Job description

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting, and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

PRIMARY RESPONSIBILITIES

• Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks, and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.
• Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols, and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.
• Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes, and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.
• Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process.
• Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.
• Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.
• Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.
• Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.
• Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.
• Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required.
• Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides, and policy. Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.
• Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others. Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.
• Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).
• Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.
• Perform any other job-related duties as required or that may arise in the future.

EDUCATION / EXPERIENCE

• Bachelor’s degree in science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage.
• At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

LICENSES AND/OR CERTIFICATIONS

• CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.
• Chemical Licensee, preferred.

TECHNICAL COMPETENCIES

• Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts, and theories in innovative ways. Demonstrated analytical and problem-solving skills. Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.
• Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes, and modifications.
• Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.
• Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.
• Fully Bilingual, excellent oral and written communication in both English/Spanish languages.
• Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas, and metrics.