Senior Quality Control Associate

Senior Quality Control Associate at Aequor Senior Quality Control Associate at Aequor in Fuquay Varina, North Carolina Posted in 7 days ago.

Type:

full-time

Job Description:

Quality Control Senior Associate with GMP, HPLC, Analytical Testing and Chemistry/Biochemistry Experience (Onsite Job in Holly Springs, NC)

Location:

Holly Springs, NC Terms:

Contract W2

Only Duration :

12 Months Contract (Will Get Extended for Long)

Description:

Fully Onsite - Standard hours - Up to 5 days per month may require shift flexibility. Responsibilities Under minimal supervision, the successful candidate will support the QC organization by:

• Conduct analytical testing, in accordance with SOP's, to characterize various substances and materials.
• 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.
• 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.
• 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.

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.

Skill Sets:

GDP/GMP Day to

Day Responsibilities:

Analytical testing Compendial review Authoring. editing and reviewing documents