Quality Specialist II

Work Schedule

Environmental Conditions

Job Description

Discover Impactful Work:

Responsible to maintain the Quality Systems in compliance with Current Good Manufacturing Practices (cGMPs), Global Regulatory requirements, company policies, procedures and all other applicable regulations and guidelines.  Mainly focus in managing the Change Control Program, Complaints and Regulatory Inspections, APR, Supplier Management, Controlled Substances Program, Quality Agreements and support audits.

A Day in the Life:

Documentation / Client Focus (80%)

• Develop/Preparation/approval and review Material Specifications, Requirements and Methods.
• Review and approve protocols and reports.
• Manage Change controls, CAPAs, approval.
• Review, approval and propose revisions to (SOPs) Operational procedures.
• Prepare client request and certifications.
• Hosting Regulatory Agency and client’s audits, reports and CAPA follow up.
• Performing Vendor/supplier Audits, reports and CAPAs follow up.
• Prepare Annual Product Review Reports.
• Controlled Substances program support and or management.
• Prepare and maintain site licensing.

Task – Safety & Compliance (5%)

• Environmental Health and Safety –identify and take actions to correct unsafe conditions.

General (15%)

• Support / prepare Metrics.

Keys to Success:

Education and Experience

• B.Sc. in Chemistry, Biology, Life Sciences or other related field.
• 2+ years’ experience in the pharmaceutical industry.
• Excellent interpersonal, oral, and written communication skills.
• Experience with Microsoft Word and Excel.
• Proficiency with the English language.
• Available for shift work

Physical Effort:

There is little physical effort and fatigue. Walks, stands, lift small objects and tools or operates keyboard equipment, and medium physical effort activity such traveling/driving.

Physical Environment:

Located in a comfortable indoor area. Any unpleasant conditions would be based on the audit to be site for a short duration.

Sensory Attention:

Regular need to attend closely to complex or subtle stimulus that requires great diligence and attention for proper interpretation.

Mental Stress:

There is regular pressure from deadlines, accuracy, or similar demands.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will gladly provide reasonable accommodations covered under the ADA.