About the Role
The QC Reviewer is responsible for performing the quality control reviews of data generated and work conducted in the laboratory to ensure accuracy, compliance, and adhere to applicable standards.
What You’ll Do Here
Ensure all batch-related documentation is completed accurately and in a timely manner by the analysts and that all procedures are respected as per the company’s SOPs
Perform daily in process quality control for batches ongoing in the laboratory
Support responses to QA reports
Monitor the quality within the laboratory according to GLP, regulatory agencies requirements and internal SOPs
Support and mentor analysts in the daily laboratory documentation procedures and processes
Ensure verification of laboratory instruments is performed as required by the internal procedures
Ensure harmonization of techniques, process and documentation between analysts in the laboratory
Escalate quality issues or trends to the line manager and participate in their resolution
May be assigned to participate in laboratory inspection: execute and report deviations and any health and safety concerns
Based on training, can draft study documents for BPI review such as Memo to File, SOP/Protocol/Study Plan deviations. and perform quality control batch review by performing multi-batch trend analysis, and compile study documentation
Based on training, can provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate for the review of the Bioanalytical Principal Investigator
Assist in planning sample analysis by maintaining timeline and scheduling commitments.
Stay up to date with SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues and observe all company guidelines and policies
Adhere to Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures
What You’ll Need to Succeed
College degree in Chemistry, Biochemistry, Math or Immunology or equivalent field.
Two years of experience in the medical and/or pharmaceutical fields, a plus
Technical Skills: MS Word, Excel, Outlook and Power Point
Ability to read and interpret technical documents and industry specific manuals.
Ability to write advanced reports and correspondence.
Ability to speak effectively before groups of employees of the organization.
Excellent verbal and written communication skills.
Well developed interpersonal skills are required.
Personal/professional integrity and proven discretion in handling confidential information.
Ability to develop strong trusting relationships in order to gain support and achieve results.
Capable of managing multiple conflicting priorities.
Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
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
The pay range estimated for this position is $25.00 - $30.00 per hour. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.
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
- College degree in Chemistry, Biochemistry, Mathematics, Immunology, or an equivalent field
- Two years of experience in the medical and/or pharmaceutical fields
- Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint
- Ability to read and interpret technical documents and industry-specific manuals
- Ability to write advanced reports and correspondence
- Ability to speak effectively before groups of employees
- Excellent verbal and written communication skills
- Well-developed interpersonal skills
- Integrity and discretion when handling confidential information
- Ability to develop trusting relationships and gain support to achieve results
- Ability to manage multiple conflicting priorities
- Self-directed, motivated, and willing to take initiative
- Legal authorization to work in the United States without current or future employer sponsorship
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!
