Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information:
Located at the Inchinnan Campus within the Custom Primers Department.
Working a rotation of Earlyshift Mon-Thurs 6am-2:15pm, Fri 1pm and Backshift Mon-Thurs 2-10pm, Fri 1-9pm. (with a 7.5% shift allowance)
Positive Objective:
This position offers an exciting opportunity to support the Custom Primers Department within the Inchinnan campus with the QA release of raw materials for use in the manufacturing process for Custom Oligonucleotides and QA Batch Manufacturing Record release for shipping of finished goods. As QA Technician II, you will play a key role in ensuring all batches meet the specifications for release in accordance with internal procedures, regulatory requirements and ISO 13485 standards, while contributing the department safety, quality and operational excellence.
Essential Functions:
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Review and release batch manufacturing records (BMRs) for all Custom Primers product lines, including both individual and pooled product records.
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Review, maintain, and update SOPs, WINs, and forms (FRMs) for the Custom Primers QA team using the Product Lifecycle Management (PLM) system.
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Prepare and review Certificates of Analysis/Conformance (CofA/Cs) upon customer request, ensuring adherence to defined turnaround times.
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Approve raw materials for use in the Custom Primers manufacturing process, including retrieval, review, and storage of all associated CofAs.
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Conduct QA review of logs, records, calibration documents, and preventive maintenance (PM) forms prior to filing and archiving; utilise the asset management system to manage QA approvals as required.
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Manage the filing and archiving of QA and Custom Primers manufacturing records, ensuring efficient storage and retrieval processes.
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Participate in Practical Process Improvement (PPI) initiatives, including Gemba walks and Kaizen events, and apply continuous improvement methodologies regularly.
Education:
Requires a minimum HND in Quality or other relevant discipline, or equivalent work experience.
Experience:
Required: Minimum of 1 year of work experience in QA or QC or related field
Preferred: Experience in a cGMP environment and be familiar with COSHH and Risk Assessments for Hazardous Materials.
Knowledge, Skills, Abilities:
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Strong attention to detail and commitment to data integrity and quality standards is desired.
- Knowledge of GMP, ISO 13485, and laboratory quality systems preferred.
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Ability to work in a fast paced environment with changing priorities.
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Proficient use of Microsoft packages ( i.e Word, Excel, Powerpoint, Teams) is essential
Physical Requirements / Work Environment:
Work is conducted primarily within a laboratory environment wearing required PPE (Personal Protective Equipment) of min safety glasses, gloves, lab coat and safety shoes
Must be able to work safely with chemicals and other hazardous substances.
Contacts:
Has contact with all Custom Primers employees.
Will also liaise extensively with all other departments on matters relating to quality and service in order to uphold the Company’s commitment to Customer satisfaction. This involves working with people at all levels within the organisation as well as potentially external customers and regulatory bodies.
Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase
Excellent Benefits
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities
