About The Role
The QA Auditor reports to the QA Supervisor. This individual is responsible for carrying out systematic and independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GxPs and the applicable regulatory requirements. They are responsible for reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). They will also be responsible for building and maintaining effective working relationships throughout the organization.
What You'll Do Here
- 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 multidepartment interactions.
- Maintains necessary documentation of QA records and study files.
- Notifies management of observed quality and compliance trends in the areas inspected.
- Under supervision of a mentor/coach, performs the following tasks: SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
- Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary.
- Interprets GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
- Prepares for RQAP-GCP and/or RQAP-GLP certification.
- Carries out appropriate self-development efforts as directed.
What You'll Need to Succeed
- Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience, in the pharmaceutical industry.
Work Authorization & Sponsorship
Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.
What We Offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Benefits
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences’ Benefits Package Includes:
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Telework when applicable.
Altasciences’ Incentive Programs Include:
- Training & Development Programs
- Employee Referral Bonus Program
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Skills Required
- Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, or an equivalent field
- Equivalent combination of education and experience in the pharmaceutical industry
- Valid U.S. work authorization that does not require employer sponsorship now or in the future
What We Do
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!
