Quality Control Associate

About Us:

Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 40 different Department of Defense awards from all military branches charged with medical technology development (i.e. U.S. Army, Air Force, Navy, and Space Force), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, Congressionally Directed Medical Research Programs, and Other Transactional Authority. As a prime contractor, Critical Innovations has a 99.5% rate of on-time program deliverable achievement. For Phase II awards, the company has 100% transition rate to Phase III funding. As a fully turnkey company, Critical Innovations possesses all the necessary capabilities and experience to guide a product seamlessly from proof-of-concept through to manufacturing, regulatory clearance, and commercialization.

Winner of the MTEC 2020 Prototype of the Year Award, Critical Innovations LLC is an ISO 13485:2016 certified, 21 CFR§820 QSR (cGMP) and DCAA compliant, medical research and development company focused on creating cutting-edge solutions to health threats that span the pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on agile engineering to rapidly advance products.

Position Title: Quality Control Associate

Overview

The Quality Control Associate's responsibilities fall under three main areas:

Batch Release and Testing to Support the Product Lifecycle: Assist with developing and conducting batch release testing to ensure that in-house specifications and USP requirements are met as required. This work will involve working closely with external testing facilities, coordinating test sample preparation, drafting working instructions, sample submission, and interpreting test reports for inclusion in each product lot history record. This work will also involve testing to ensure stability and continued performance over the product lifecycle (e.g., post-shipping/handling, real-time, and accelerated aging).

Raw Material Release and Revalidation: Assist with managing initial raw material release testing to ensure that USP Monograph specifications are met (e.g., for active pharmaceutical ingredients and excipients) and for revalidation testing as required for existing in-house inventory. This work will involve working closely with external testing facilities, coordinating test sample preparation, submission, and interpretation of test reports for inclusion in each raw material lot history record.

Laboratory Activities: Assist a research team with product development, production activities, quality control, and maintenance of laboratory equipment and consumables.

This is an on-site, full-time position.

Reports to:

Preclinical and Development Senior Scientist

Duties and Responsibilities:

The responsibilities of the Quality Control Associate typically include:

• Prepare and manage test articles/products for testing, including obtaining quotes, Purchase Order preparation, Invoice processing, online sample submission, and shipment with inclusion of relevant documentation.

• Review and develop protocols, approve test results for raw material and batch release, and add the records to the relevant product/item history files.

• Evaluate documentation, write reports, graph results, and present work to cross-functional teams, including engineers, scientists, and regulatory affairs professionals.

• Provide input in biocompatibility strategy and shelf-life studies, including accelerated and real-time.

• Inventory control for laboratory supplies.

• Performing routine maintenance and calibration checks on laboratory equipment.

• Performing and documenting work in compliance with ISO 13485:2016, FDA Quality System Regulations, and Good Laboratory Practice.

• Conduct quality inspections of raw materials, in-process components, and finished products to ensure compliance with company standards and regulatory requirements.

Skills and Experience:

· Excellent Communication, both written and oral.

· Skilled at interacting with outside vendors.

· Experience working within a quality system (e.g., GLP, GMP).

· Excellent analytical and problem-solving skills.

· Strong attention to detail and ability to identify discrepancies.

· Basic understanding of relevant scientific principles and quality control methodologies.

· Proficiency in laboratory techniques and equipment operation.

· Knowledge and experience of safe storage and handling of potentially dangerous materials.

· Self-motivated with solid time management skills to ensure completion of tasks within strict timelines.

· Highly organized and detailed oriented.

· Ability to work independently and as part of a team.

· Proficient with Microsoft Office Suite.

· Must be able to lift 50 lbs.

Education and Training:

· Bachelor of Science degree, with an emphasis on biology, chemistry, or a related field.

· Minimum two years of related experience in Quality Control for Pharmaceutical products or Medical Devices.

· Knowledge or experience with ISO 13485 and ISO 10993 is preferred.

· Familiarity with laboratory safety procedures and practices.

· Authorization to work in the United States indefinitely without restriction or sponsorship.

*Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

* To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Work Remotely

• No

Job Type: Full-time

Pay: $55,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• Will you be able to reliably commute or relocate to Los Angeles for this job?

Education:

• Bachelor's (Required)

Experience:

• Quality control: 2 years (Required)

Work Location: In person