QA Analyst 1

ALS Global • Torrance, CA

1d • Onsite

About The Position

The Quality Assurance Analyst 1 will be responsible for coordinating the quality assurance and quality control functions of the laboratory. This individual will work with the QA Director to implement quality programs and make necessary updates to maintain compliance with corporate quality programs and lab accreditation, where applicable.

Requirements

• Bachelor’s degree in Chemistry
• 0-2 years relevant laboratory / pharmaceutical industry experience.
• Familiarity with electronic Document Control system (e.g., CompliantPro) preferred.
• Knowledge of documentation functions within a cGMP or ISO regulated environment.
• Good communication and organizational skills
• Proficient verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Proficient computer skills, specifically Microsoft Office and Adobe Acrobat.
• Remains flexible, professional, and patient when dealing with changing priorities and assignments.
• Comprehension and awareness of the importance of achieving regulatory compliance.
• Follow all company operating procedures, standards, policies, and training to ensure the safe and efficient operation of the site.
• Play an active role in the ALS safety program by correcting or reporting unsafe acts and conditions that are observed during the day-to-day operations to create a zero-injury work environment.
• Participate in and support HSE initiatives, as required by ALS leadership.
• Understand and use HSE precautions (such as but not limited to fume hoods and PPE) while working with chemicals and samples of unknown hazards.
• Ensure the health and safety of staff, contractors, and/or visitors by providing appropriate leadership, due diligence, resources, training, and enforcement for all individuals onsite.
• Monitor and enforce the health, safety and environment policies, procedures and ensure compliance with the relevant regulations.
• Actively promote awareness of these policies, procedures, and regulations amongst company personnel.
• Actively support and participate in all OHS initiatives.
• Lead by example.
• Report all personal injuries and incidents and assist with investigations as per company policy.
• Ensure the company sites adhere to all environmental requirements as determined by government legislation, regulation, and company policy.
• Ensure business is conducted in accordance with Core Values: Safe Resilient Curious Committed Caring Honest
• Ensure Quality Systems are adhered to in performance, review, and reporting of laboratory duties and communicate all quality issues.
• Support Quality Department and Continuous Improvement Processes.
• Employees commit to improving the ALS experience through effective communication.
• Take appropriate steps to foreshadow potential risks and establish contingency plans.
• Ensure all statutory management and reporting requirements are met.
• Ensure compliance and continuous improvement of the Quality Management System.
• Working at a computer, up to eight (8) hours per day.
• Sitting and/or standing for extended periods of time, up to eight (8) hours per business day.
• Must be able to sit, stand, bend, push, pull, stoop and crouch up to 50% of the time while performing the duties of this position.
• Position may require the lifting of items up to 25 lb in weight.
• To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.

Nice To Haves

• Familiarity with electronic Document Control system (e.g., CompliantPro)

Responsibilities

• Review of raw data and associated analytical reports for accuracy and compliance.
• Final report review and QA release.
• Review of validations and method transfers as assigned for Chemistry and Microbiology.
• Perform daily verification of Chemistry and Microbiology balances, including coordination of verification activities if balance requires moving.
• Media batch record generation, review, release, filing and archival.
• Oversight of DEA sample receipt from Clients, Controlled Substance program management and coordination of disposal process.
• Perform review of instrument calibration / validation documents as needed.
• Oversight of manual monitoring of Temperature Controlled units and associated investigations.
• Oversight of Vendor Qualification Program to ensure vendor certifications are within expiry date.
• Perform review / approval of Deviations, OOS Investigations, Corrective / Preventive Action (CAPA) proposals and other requests as assigned.
• Ensure all procedures relevant to the department are followed.
• Revise procedures relevant to job description and expertise.
• Perform Internal Audits and follow up with recommendations and corrective actions.
• Oversee and monitor all work performed for GLP studies.
• Assist other QA staff members in finalizing Internal Audit reports for distribution.
• Participate in training of quality, laboratory and administrative staff as needed.
• Assist with Blue sheet review and QA release, if requested.
• Assist with trending documentation for Management Review as needed.
• Perform all duties following current SOP’s.
• Practice proper cGDP.
• Maintain a clean and orderly workspace.
• Exercise Laboratory safety practices.
• Other duties as required.

Benefits

• We invest in our people with programs and opportunities that help you build a diverse career with us.
• We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.
• Reasonable adjustments to support candidates throughout the recruitment process are available upon request.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level