QA Analyst

Primary Objective

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 the quality programs and make necessary updates to maintain compliance with the corporate quality program and lab accreditation, where applicable.

• Review of raw data and associated with analytical reports for accuracy and compliance.
• Final report review and QA release.
• Review of validations, 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 vendors certifications are within expiry date.
• Perform review / approval of Deviations, OOS Investigations, Corrective / Preventive Action (CAPA) proposals and other requests as assigned.
• Ensure all produces application 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.

• Bachelor’s degree in Chemistry with 0–2 years relevant laboratory / pharmaceutical industry experience.
• Familiarity with electronic Document Control system (e.g., Compliant Pro) 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…