Overview

Imagine your future with us!

At ALS, we encourage you to dream big. When you join ALS, you join a purpose and values-driven team that empowers you to innovate, create, and thrive. Our global team turns up each day with passion and commitment to do amazing things, always challenging our thinking to find ways to solve some of the world’s most complex problems for a safer, healthier world.

About the role:

The Quality Assurance Manager will be responsible forworking with applicable departments in the implementation, performance, and management of quality activities.

Responsibilities

About you:

• Implement policy and procedures to maintain the regulatory compliance of the facility.

• Provide quality & regulatory technical guidance to Process Development, Laboratory Operations, and Software Departments.

• Host vendor and regulatory agency audits of the CA Pharma or any other USA based Pharma Assist with other locations as required Administrator and primary contact for the Torrance Pharma facility CAPA program.

• Representing Quality Assurance, perform project reviews, approvals, and releases.

• Perform and document internal facility and data quality audits.

• Maintain follow-up on audit issues until completion, while providing corrective action support.

• Quality/ Management Representative for FDA, ISO 9001:2015, ISO17025;2017 and other agencies as needed.

• Manage SOP and regulated documentation systems.

• Maintain the Quality Systems, including Change Control and OOS systems.

• 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.

• Assist in assay, software, and instrumentation troubleshooting activities.

• Interact with QC personnel from the various departments to monitor QC programs and provide feedback for improved quality.

• Assist in the preparation of new SOPs or revisions.

• Develop and provide quality metrics to management.

• Perform quality and regulatory related training.

• Represent ALS’s quality activities to current or potential customer.

• Hire and terminate QA personal as needed.

• Other duties as may be required.

Required Qualifications:

• Previous pharmaceutical industry experience, specifically in a GMP or GLP environment, in Quality Assurance or regulatory compliance.

• Strong organizational and leadership skills.

• Previous supervisory experience preferred

• Experience with regulated software design, including 21 CFR Part 11 compliance.

• Previous pharmaceutical industry experience in validation documentation preparation and execution.

• Familiarity with ICH, ISO and international regulations.

• Experience in conducting audits.

• Project management skills.

• Bachelor’s degree (B.S.) or Bachelor’s Arts plus 3 years’ experience.

• 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.

Physical Demands:

• 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.

• Must be able to travel within USA and Internationally as needed.

Qualifications

Working at ALS:

Our people are our most valuable asset and drive our success at ALS. We are a diverse community of dedicated professionals united by our passion to make a difference in the world. We reward excellence and uphold our values in our work and how we treat each other. At ALS, you’ll be supported to expand your skills and develop new ones so you can reach your full potential. We invest in our people with a range of programs and provide opportunities across the company, giving our people scope to grow diverse careers and develop as leaders. We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and the communities where we work.

Our benefits include:

• Structured wage increases Min $63,262.00 Max $80,976.00

• Comprehensive benefit package (including: medical, dental, and vision coverage, life and disability insurance, retirement plan with company match, employee assistance and wellness programs, access to company perks)

• Additional vacation days for years of service

• Business support for education or training after 9 months with the company

• Learning & development opportunities (unlimited access to e-learnings and more)

About ALS:

ALS is a global leader in scientific testing, providing comprehensive testing solutions to clients in more than 60 countries across a wide range of industries, including environment, food and beverage, mining, personal care, pharmaceutical, healthcare and equipment reliability. Using state-of-the-art technologies and innovative methodologies, our dedicated international teams deliver the highest-quality testing services and personalised solutions supported by local expertise. We help our clients leverage the power of data-driven insights for a safer and healthier world.

Everyone matters:

ALS is proud to be an equal opportunity employer committed to achieving and maintaining a workforce which reflects and affirms the diversity of our society

ALS is a VEVRAA Federal Contractor.

EOE AA Minority, Female, Veteran, Individuals with Disabilities

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ALS also welcomes applications from people with all levels of ability. Accommodation is available on request for candidates taking part in all aspects of the selection process.

Location US-CA-Torrance

Job ID 2024-10948

# Positions 1

Posted Date 1 week ago (11/21/2024 1:45 PM)

Category Quality Assurance

Type Regular Full-Time

OC ALSENV