Quality Control Reviewer (BSD)
Manufacturing & operationsDescription
Your new company!
At Altasciences, we all work together to contribute to the discovery, development, and manufacturing of new medicinal therapies so they can reach people who need them faster. No matter what your role, we all play an important part, and you will have a significant impact on the health and well-being of people around the world. In keeping with our values of employee development, customer focus, quality and excellence, respect, and integrity, we are looking to foster a passionate and collaborative work environment and are looking for talented and enthusiastic people like you to join our growing team! Whether you are a recent university graduate or looking for your next career opportunity, it's time to discover your future at Altasciences.
We are better together, and that is how we are Altasciences.
About the role
The Quality Control Reviewer is responsible for ensuring the quality control of data generated and work performed within the laboratory.
What you will do here
- Ensure that all lot documentation is completed accurately and on time by analysts, and that all procedures are followed in accordance with the company's Standard Operating Procedures (SOPs).
- Based on your training, you may write study documents for review by the Bioanalytical Principal Investigator (BPI), such as study notes, SOP, protocol, or study plan deviations; perform quality control of lots by performing trend analyses on multiple lots; and compile study documentation.
- Based on your training, provide final reports and/or results within the timeframes set by the study, ensure that any deviation, exception, or event is recorded appropriately, and ensure that all analyses performed are recorded and accurate for review by the Bioanalytical Principal Investigator.
- Based on your training, be responsible for daily quality control during manufacturing for lots in process at the laboratory.
- Report any quality issues or trends observed to your supervisor and participate in the resolution of these issues appropriately.
- Provide support in responding to quality assurance reports.
- Monitor quality within the laboratory in accordance with Good Laboratory Practices (GLP), regulatory requirements, and internal Standard Operating Procedures (SOPs).
- Guide and support analysts in the laboratory's daily documentation procedures and processes.
- May participate in basic laboratory staff training.
- May be responsible for ensuring that laboratory instrument verification is performed in accordance with internal procedures.
- May be responsible for harmonizing techniques, processes, and documentation among laboratory analysts.
- May be involved in laboratory inspections: report any observed discrepancies and any health and safety issues.
- Depending on the tasks assigned, participate in the planning of sample analysis while respecting deadlines and planning commitments.
- Stay informed of new Standard Operating Procedures (SOPs), new methods, and new techniques through training sessions, team meetings, and internal communication channels, and respect all company policies and directives.
- Follow health and safety standards regarding personal protective equipment, laboratory maintenance, and work procedures.
What you will need to succeed
- College and/or university degree in chemistry, biochemistry, or immunology, or in an equivalent field.
- Relevant experience may be considered as a substitute.
- Experience in the medical and/or pharmaceutical sectors, with generally 3 years of experience in data analysis and quality control.
- Proficiency in Standard Operating Procedures (SOPs) and knowledge of GLP regulations.
- Proven sense of organization.
- Strong attention to detail regarding sample preparation procedures and raw data processing.
- Strong communication and leadership skills.
- Ability to work cross-functionally.
- Good proficiency in MS Office.
Altasciences strives to offer a French-speaking work environment to its employees in Quebec. Altasciences has taken all reasonable measures to avoid imposing the requirement to speak another language than French mentioned above. This requirement is essential for the Quality Control Reviewer position, among others, for the following reason(s):
The obligation to have study protocols, designs, and clinical research documents written and documented in English as required by the industry's regulatory agencies.
What we offer
Altasciences offers a wide range of benefits to help our employees lead a healthy and fulfilling life, both at work and outside of it.
The Altasciences benefits program includes:
- Health, dental, and vision insurance
- A 401(k)/REER plan with employer contribution
- Paid time off and holidays
- Paid sick and bereavement leave
- Employee assistance and telehealth programs
Altasciences' incentive programs include
- Training and development programs
- Employee referral bonus program
- Annual performance evaluations
- WE MOVE TOGETHER TO ACHIEVE MAXIMUM IMPACT WHILE OFFERING A PERSONAL TOUCH.
Altasciences is an equal opportunity employer and is committed to promoting diversity and inclusion. Our goal is to attract, develop, and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide range of experiences and perspectives. All qualified candidates will be considered for employment without regard to age, race, color, religion, belief, sex, sexual orientation, gender identity, national origin, disability, or any other protected status under applicable law. Reasonable accommodations for individuals with disabilities are available upon request during the recruitment process. Join us at Altasciences!
This posting was aggregated from indeed. Groupe Sentinella is not the employer; applying takes you to the original site. The full text belongs to the original poster.
Want us in your corner?
Join the Sentinella talent bench. We'll reach out when a mandate matches your profile — including roles like this one.
Join the talent bench