At ALS, we encourage you to dream big.
When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.
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 QA Director to implement the quality programs and make necessary updates to maintain compliance with corporate quality program and lab accreditation, where applicable.
Position Duties and Scope:
- The Quality Assurance Analyst 1 has the following duties:
- 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.
Position Requirements/
Essential Criteria:
- Bachelor’s degree in Chemistry with 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
Core Competencies:
- 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.
Occupational Health & Safety Responsibilities:
- 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.
Quality Responsibilities:
- 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.
Other Requirements:
- 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.
Working at ALS
The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.
Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence.
At ALS, you’ll be supported to develop new skills and reach your full potential. 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.
Everyone Matters
ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.
Qualified candidates will be considered without regard to race, colour, religion, national origin, military or veteran status, gender, age, disabilities, sexual orientation, gender identity, pregnancy and pregnancy-related conditions, genetic information and any other characteristics protected by the law. We invite resumes from all interested parties, including women, members of minority groups, and persons living with disabilities.
ALS also welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request.
Eligibility
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.
How to apply
Please apply on-line and provide a resume & cover letter that best demonstrate your motivation and ability to meet the requirements of this role.
