Analytical Chemist (Quality Control Analytical Testing)

Aequor; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Aequor is seeking a Quality Control Senior Associate in Holly Springs, NC for a 12-month contract. This fully onsite role involves conducting analytical testing, managing laboratory samples, and maintaining equipment. The ideal candidate holds a degree in a scientific field and has at least 4 years of experience in a GMP manufacturing environment. Strong skills in laboratory techniques and communication are essential. Competitive salary and opportunities for extension may be available.

Qualifications

• High school/GED with 2 years work experience or Associate’s with 6 months work experience.
• Bachelor's degree in a related scientific field is acceptable.
• 4+ years of laboratory experience in GMP commercial manufacturing is preferred.

Responsibilities

• Conduct analytical testing according to SOPs.
• Perform assays and laboratory procedures.
• Evaluate data analysis and apply GMP procedures.
• Manage samples and documentation efficiently.

Skills

Laboratory techniques

Communication skills

Analytical testing

HPLC

Knowledge of regulatory issues

Education

Degree in a related scientific field

High school/GED

Bachelor’s degree

Tools

LIMS

HPLC equipment

TOC

Job description

Job Title: Quality Control Senior Associate

Location: Holly Springs NC – 100% onsite

Duration: 12 Months with possible extension

Terms: Contract W2

Description:

Fully Onsite - Standard hours - Up to 5 days per month may require shift flexibility.

Responsibilities

• Conduct analytical testing, in accordance with SOP’s, to characterize various substances and materials.
• Perform variety of assays and routine laboratory procedures under minimal supervision and in accordance with SOP’s.
• Maintains equipment to uphold laboratory standards.
• Manages samples efficiently ensuring proper handling and documentation.
• Evaluates data analysis and applies GMP procedures.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Experience with for HPLC, UPLC, TOC, UV and other related Chemistry bench top Equipment (OSMO, Turbidimeter, pH and Conductivity).
• Participating in the QC Chemistry testing activities including validation and method transfers.
• Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
• Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Ensure successful training and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
• Own and manage Deviation, CAPA and Change Control records to support Quality Control.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Support routine activities over the weekends and public holidays as required

Basic Qualifications

High school/GED + 2 years work experience OR Associate’s and 6 months work experience OR Bachelor’s

Preferred Qualifications

• Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
• 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Strong knowledge of laboratory techniques.
• Proficient in the use of LIMS & LMES/CIMS.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.