QC Specialist III LIMS and Operational Support

Astellas Pharma • Sanford, NC

403d

About The Position

The QC Specialist III LIMS and Operational Support is responsible for providing system administration and master data support for the QC LIMS application. This role acts as the primary interface between Quality Control (QC) and IT, ensuring the ongoing operations and maintenance of LIMS usage. The specialist will collaborate with various stakeholders to enhance compliance and efficiency, manage LIMS configurations, and support the implementation of other QC tools. This position is crucial for maintaining the integrity and accuracy of laboratory documents and ensuring compliance with regulations.

Requirements

• B.S. degree in biological sciences, cell biology, chemistry, or related field with 5+ years or M.S. degree with 3+ years of relevant experience in working with analytical computerized systems.
• Prior laboratory hands-on experience with a variety of analytical computerized systems.
• Experience using LIMS as an end user (e.g., QC Analyst performing data entry in LIMS).
• Experience as a System Administrator for QC Laboratory computer systems (including LIMS, Empower).
• Expertise in regulations governing data integrity and computerized systems.
• Experience in qualification of analytical equipment, including those with computerized systems.
• Experience with MasterControl or other EDMS (Electronic Data Management System).
• Strong interpersonal skills and ability to collaborate within a multi-discipline team.
• Strong knowledge of GMP, SOPs, and quality control processes.
• Good to excellent technical writing skills and verbal communication skills.
• Ability to excel in a fast-paced team environment and handle multiple tasks concurrently.

Nice To Haves

• Experience and knowledge in implementation and management of LIMS.
• Experience in translating laboratory user requirements to IT implementations.
• Experience with Windows OS, domains, networks, and basic computing infrastructure in lab environment.
• Experience conducting data integrity assessments and associated remediation activities.
• Experience serving as a change agent and driving continuous improvement and automation across QC.

Responsibilities

• Collaborate with QC laboratory users to define master data requirements for ongoing LIMS operational usage and provide solutions for continuous improvement enhancements in compliance and efficiency.
• Translate business requirements into technical solutions in LIMS with QC Lab stakeholders.
• Develop user requirements and configuration documents in collaboration with cross-functional groups (QA, Validation, IT, etc.).
• Support and maintain LIMS configuration documentation and plan for new products, equipment, and workflows.
• Assist in managing the operations of LIMS in a validated environment and develop policies and procedures related to compliance requirements.
• Troubleshoot LIMS issues for QC users and provide first-line support.
• Develop, revise, and review SOPs, protocols, and reports to support QC equipment and LIMS.
• Provide training to new users and grant system access for computerized systems and LIMS.
• Perform business administration activities for other QC Lab software such as Empower and LabX systems.
• Support lab compliance with applicable cGMP regulations and SOPs, and assist with internal and external audits.
• Initiate and project manage change controls for QC lab computer systems.
• Collect, report, track, and maintain metrics for QC systems/equipment and users.
• Provide guidance and training to junior colleagues and oversee training activities for groups.
• Ensure the integrity and accuracy of all laboratory documents and assess overall document compliance.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree