Analyst (Raw Materials), Quality Control
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
As a Quality Control Analyst, you will play a pivotal role in our organization by championing quality assurance practices and driving excellence throughout our product development lifecycle. Through testing and analysis, you will conquer challenges, drive innovation and uphold regulatory compliance. You’ll work collaboratively with cross-functional teams to identify areas for improvement, drive process enhancements, and maintain adherence to regulatory requirements.
- Conduct thorough visual inspections of purchased materials (up to 60lbs), such as chemicals, buffers, or components used in laboratory and/or manufacturing operations, ensuring adherence to internal raw material specifications.
- Review supplier Certificates of Analysis (CofA) to assess compliance with internal specifications, evaluating the quality and suitability of the materials received.
- Review and approve assays and associated documents to authorize the release of materials, ensuring they meet the required quality standards.
- USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs.
- Perform aseptic sampling of raw materials and components, maintaining sterility and adhering to proper sampling techniques to ensure the integrity of the materials.
- Review, write, and revise internal documents such as Standard Operating Procedures (SOPs), Test Methods (TM), Raw Material Specifications (RMS), and forms, utilizing the Document Change Request (DCR) process to ensure accuracy and compliance.
- Foster effective communication and collaboration with external vendors/suppliers of raw materials and components, maintaining strong relationships and facilitating smooth interactions.
- Provide training and supervision to junior analysts, overseeing and guiding their experimental work to ensure accuracy and adherence to quality standards.
- Other tasks as assigned.
Minimum Qualifications:
- Bachelor’s degree in chemistry/biology or equivalent industry experience.
- 2+ years of experience in a QC or analytical lab.
- Strong understanding of quality control principles, processes, and methodologies.
- Knowledge of relevant regulations and standards, such as Good Manufacturing Practices (GMP), ISO standards, or specific industry guidelines.
- Familiarity with analytical techniques and instrumentation commonly used in quality control.
- Experience with documentation and record-keeping in a regulated environment.
- Strong attention to detail, accuracy, and adherence to procedures.
- Excellent problem-solving and troubleshooting skills.
- Effective written and verbal communication skills.
Position Type/Expected Hours of Work:
This role is a full-time position. Days of work are Monday through Friday. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $26.73 to $35.00 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.