QC Reviewer

QC Reviewer

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

1. 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
2. Perform daily in process quality control for batches ongoing in the laboratory
3. Support responses to QA reports
4. Monitor the quality within the laboratory according to GLP, regulatory agencies requirements and internal SOPs
5. Support and mentor analysts in the daily laboratory documentation procedures and processes
6. Ensure verification of laboratory instruments is performed as required by the internal procedures
7. Ensure harmonization of techniques, process and documentation between analysts in the laboratory
8. Escalate quality issues or trends to the line manager and participate in their resolution
9. May be assigned to participate in laboratory inspection: execute and report deviations and any health and safety concerns
10. 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
11. 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
12. Assist in planning sample analysis by maintaining timeline and scheduling commitments.
13. 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
14. 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