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QA Specialist

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Altasciences

Oct 3, 2024

  • Job
    Full-time
    Senior Level
  • Laval
  • Quick Apply

AI generated summary

  • You need a Bachelor's in a relevant field, 5 years in pharma, knowledge of GCP/GLP/GMP, strong detail orientation, project management skills, bilingual in French and English, and Microsoft Office proficiency.
  • You will audit studies for compliance, write reports, mentor staff, identify process improvements, maintain QA documentation, and interpret regulatory guidelines for quality initiatives.

Requirements

  • Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of five years experience, or equivalent combination of education and experience, in the pharmaceutical industry.
  • Knowledge and understanding of the applicable Canadian, US, European, and ICH pharmaceutical regulations and guidelines, for phase I research studies (i.e., GCP, GLP, and GMP).
  • Detail oriented.
  • Project management and coordination skills.
  • Ability to meet tight deadlines.
  • Tactful, reliable, persuasive, dependable, consistent, flexible.
  • Good written and oral communication skills in French and English.
  • Software: Microsoft Office.

Responsibilities

  • Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements) to ensure regulatory compliance.
  • Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services).
  • Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
  • Writes and issues inspection reports. Works with internal clients to ensure that inspection findings are clearly communicated and understood. Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
  • Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
  • Identifies and communicates opportunities for process improvement based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multidepartmental interactions.
  • Maintains necessary documentation of QA records and study files.
  • Notifies management of observed quality and compliance trends in the areas inspected.
  • Autonomously performs and is able to mentor/coach staff on SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
  • Interprets FDA, Health Canada and EMA submission regulations to facilitate auditing and process improvement recommendations.
  • Autonomously performs project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
  • Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary.
  • Subject Matter Expert and can train on GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
  • Mentors other employees seeking RQAP-GxP certification.
  • Carries out appropriate self-development efforts as directed.

FAQs

What is the primary responsibility of the QA Specialist at Altasciences?

The primary responsibility of the QA Specialist is to carry out systematic and independent examinations (audits) of trial-related activities and documents to ensure compliance with protocols, standard operating procedures (SOPs), GxPs, and applicable regulatory requirements.

What qualifications are needed to apply for the QA Specialist position?

A Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, or a related field, along with a minimum of five years of experience in the pharmaceutical industry, or an equivalent combination of education and experience is required.

Are there opportunities for professional development and training?

Yes, Altasciences offers a variety of training and development programs as part of their incentive programs.

What regulatory knowledge is necessary for this position?

Candidates should have knowledge and understanding of applicable Canadian, US, European, and ICH pharmaceutical regulations and guidelines, specifically for phase I research studies, including GCP, GLP, and GMP.

Does this job require bilingual skills?

Yes, good written and oral communication skills in both French and English are required for this position.

What types of audits will the QA Specialist conduct?

The QA Specialist will perform audits of laboratory and clinical studies, as well as audits of all disciplines including Screening, Recruiting, Clinical Operations, Laboratory, SRA, and Data Services.

What benefits does Altasciences offer to employees?

Altasciences offers a comprehensive benefits package, including health/dental/vision insurance, a 401(k) with employer match, paid vacation and holidays, paid sick and bereavement leave, employee assistance and telehealth programs, and telework options when applicable.

Is mentoring part of the QA Specialist's role?

Yes, the QA Specialist is responsible for mentoring and coaching lower-level staff and can also mentor employees seeking RQAP-GxP certification.

What skills are essential for success in this role?

Detail orientation, project management and coordination skills, the ability to meet tight deadlines, and being tactful, reliable, and flexible are essential skills for success in this role.

How can applicants expect the hiring process to accommodate disabilities?

Altasciences is committed to providing reasonable accommodations for persons with disabilities during the recruitment process upon request.

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Altasciences

Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.

Science & Healthcare
Industry
1001-5000
Employees
1992
Founded Year

Mission & Purpose

Outsourcing made easy with a one-stop solution to early phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!

Culture & Values

  • Respect

    We are open to differences of opinions and value different viewpoints. We treat each other, our customers, participants in our studies, and the research animals in our care with dignity.

  • Quality and Excellence

    We provide services and solutions of the highest quality, and pride ourselves on challenging the status quo. We strive to exceed expectations by truly giving our best at everything we do.

  • Integrity

    We are honest and uphold strong moral principles. We conduct our business with transparency and high ethical standards.

  • Customer Focus

    We actively partner with our clients. We listen, remain accessible, deliver on commitments, and maintain open channels of communication to build and nurture a lasting relationship based on trust.

  • Employee Development

    We provide leadership, encourage professional development, recognize individual and team contributions, and offer a stimulating, safe working environment.