Quality Control Supervisor Manager

Title: Quality Control System Manager

Location: Holly Springs, NC

Duration: 12 Months Contract with extension

Top 3 Must Have Skill Sets:

1. Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.

2. Experience leading QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing

3. Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup

The team is looking for three different specialties

1) Analytical validation & method

2) Both analytical validation & method experience and writing quality risk assessments (QRA's) for lab sample chain of custody.

3) Strong background in sample, stability, and reserve management. This person is going to assist in implementing the processes in place for the new site.

Ideally the candidate will have extensive diversified experience in commissioning of Quality Control (QC) Equipment supporting all QC laboratories, (Chemistry, Bioassay, Raw Material, and Microbiology). The candidate must have at least 15 years of functional experience and capable of leading technical documentation supporting Analytical Method Validation/Verification required to support GMP QC Laboratory readiness activities at the *** North Carolina facility.

Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.

Core Analytical Competencies must include, but not limited to, HPLC/UPLC, HPIC, SEC (UV, CAD, ELSD, Fluorescence, Conductivity)K-F, TOC, ELISA, cell based assays, peptide mapping, glycan, aggregate and excipient analysis, and sample preparation techniques.

Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup

Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP)

Manage document lifecycle updates to support QC Laboratory Readiness metric reporting

Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications to support ANC QC Laboratory Readiness as necessary

Provide validation and change management support for Laboratory Equipment/Method Readiness.

Lead QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing

Provide incident management support associated with nonconformances

Identify technical/operational gaps and propose solutions.

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

Thanks

Dimpul Kumar

1 650-618-3908

dimpulk@aditiconsulting.com

1 650-618-3908