Quality Assurance Specialist I - Therapeutics

Axolabs specialises in a new class of drugs whose active ingredients are chemically derived from DNA or RNA. They are called oligonucleotide or nucleic acid therapeutics. We use our many years of expertise to help our clients make them a success. Some of these drugs have already been approved and are being used successfully against diseases that were previously untreatable in some cases. New drugs from this class are added every year.

We believe in Science for a Safer World and are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization. LGC Axolabs is located in Petaluma, US, Kulmbach and Berlin, Germany.

Job Description

Roles and Responsibilities

• Quality & Compliance: Complete all activities adhering strictly to quality and regulatory standards and procedures. Foster a focus on quality and strive for excellence in every task.
• Continuous Improvement: Cultivate a culture of continuous improvement by demonstrating industrial excellence methodologies, lean metrics, and key performance indicators.
• Raw Material Release: Review of incoming Raw Material records for completeness and disposition
• Batch Review: Perform technical review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. Review batch records, summary reports and other release documentation as necessary.
• Accountability: Support employees and departments by communicating clearly and acting. Ensure proactive communication with customers for timely issue resolution and partner concern. Facilitate cross-functional communication effectively.
• Environment Health & Safety: Ensure compliance with LGC’s safety and environmental guidelines.
• Quality Systems: Support the following quality processes: Change Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation.
• Quality Operations: Support the following quality processes: Change Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation
• Other Duties as mandated by site priorities and Quality, Business, or Safety requirement.

Qualifications

Qualifications

Minimum

Qualifications

• A 4-year college degree in Engineering, Chemistry, Biochemistry, Biological Sciences, or a related field, or an equivalent combination of education, training, and industry experience.
• Need 1- 4 years in Manufacturing, Quality Control, or Quality Assurance in pharmaceutical settings.
• Proficiency in MS Office software applications (Word, Excel, PowerPoint, Outlook).
• Strong technical writing and interpersonal skills.

Preferred

Qualifications

• Experience in CAPA, Deviation and Nonconformance reporting, internal auditing, and supplier management.
• Extensive knowledge of ICH, FDA/EMA regulations for Active Pharmaceutical Ingredients and/or Finished pharmaceuticals.
• Lead auditor training and/or certification.

Proficiencies & Behaviours

• Outstanding interpersonal and communication skills.
• Resonates with and operates in line with LGC’s core values: Passion, Curiosity, Integrity, Brilliance, and Respect.
• Promotes teamwork and dedication to achieving goals and deliverables.

Physical Requirements

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information

The typical pay range for this role is :

Minimum: $ 32.50 per hour USD

Maximum : $ 35.00 per hour USD

This range represents the low and high end of the anticipated salary range for the California-based position. The actual base salary will depend on several factors such as experience, skills, and location.

About LGC

LGC is a top life science tools company, offering important components for key industries.

Our Values:

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities:

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or birthing parent, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website

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