QC Micro Analyst

Overview

Conduct QC microbiology testing, method qualification, and ensure cGMP compliance.

Key Responsibilities

• qc testing
• data integrity
• sop authoring
• change control
• capa management
• method qualification

Tasks

-Writing and updating SOPs. -Ensure that cGMP standards are maintained at all times. -Perform and support QC analytical activities including in-process, release and stability related testing. -Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations -Serve as an SME for regulatory and internal inspections and audits. -Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality. -Provide day to day direction and scheduling to the QC analyst team. -Author/review technical documents, standard operating procedures and actions for the performance of laboratory methods. -Participate in risk assessments and implement and follow-up on corrective / preventative measures. -Accountable for change control process and mechanisms required to maintain a state of continued compliance for the methods. -Work cross-functionally to build and operate testing capability within the lab. -Responsible for the qualification, maintenance, and/or integration of the QC methods, in compliance with up-to-date data integrity, regulatory, and industry standards. -Ensure training is current for all job functions performed -Manage deviations, CAPAs and change controls. -Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.

Requirements

• qc digital
• lims
• microbiology
• 5 years
• troubleshooting
• pharmacopeia

What You Bring

-Strong organisational skills -Working knowledge of QC Digital Systems (eLogs, Electronic Lab Notebook, LIMS etc.) -Ability to think logically and be proactive -Good attention to detail -Ability to respond to changing priorities -Good verbal and written communication skills -5 years industry experience with significant knowledge and experience working in a Microbiology Laboratory in a pharmaceutical company -Ability to work as part of a team and on own initiative in a constructive manner -Excellent troubleshooting and problem-solving skills -Experienced in testing as per the pharmacopeia’s

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About Orion Group

-Founded in 2019 by a trio of entrepreneurs with a mission to consolidate boutique family-owned service brands. -Partnerships include Jackson Mechanical and specialized platforms in chiller, refrigeration, controls, and heavy mechanical. -Typical projects include multi-site retail HVAC roll-outs, preventive maintenance contracts, and large-scale landscape and snow-management programs. -Commercial landscaping services under its SunWorks banner manage grounds for corporate campuses and distribution hubs nationwide. -Its facilities maintenance network offers interior handyman, roofing, fencing, plumbing, locksmith, and exterior lot care with tech-driven coordination.

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