Quality Control Biochemistry Associate

SGS Consulting; Charlotte (NC); Vor Ort; USD 42.000 - 62.000; Vollzeit

Zusammenfassung

SGS Consulting in Charlotte, NC seeks an Associate II in Biochemistry QC to support testing and ensure adherence to GLP/GMP. You will execute in-process testing, release testing, and method transfers, while applying Client Quality Systems in daily operations.

The role emphasizes written and verbal communication, teamwork across Quality and manufacturing, and investigations. A BS in science with 2+ years (or MS) is required, with knowledge of pH, osmolality, and protein concentration testing.

Qualifikationen

• B.S. degree in science; 2+ years relevant experience, or MS with relevant experience.
• Experience with QC biochemistry testing and GLP/GMP requirements.
• Strong written and verbal communication skills.

Aufgaben

• Test pH, Appearance, Osmolality, and Protein Concentration.
• Apply Client Quality Systems in daily support functions.
• Ensure adherence to GLP/GMP requirements; interface with Quality and manufacturing.
• Support investigations impacting the QC department.
• Work effectively within the group, within Quality and across site.
• Maintain solid written and verbal communication skills.
• Perform in-process, release testing, method transfer and validation support activities/testing.
• Support investigations including testing (85%); QC Biochemistry operations related to schedules (10%); maintenance of laboratory systems (5%).

Kenntnisse

Quality Control

Biochemistry Testing

In-Process Testing

Release Testing

Method Transfer

Validation Testing

GLP/GMP Compliance

pH Testing

Appearance Testing

Osmolality Testing

Protein Concentration Testing (UV, RI,

Quality Systems

Investigation Support

Laboratory Systems

Written and Verbal Communication

Ausbildung

B.S. in Science

Jobbeschreibung

Job Responsibilities:

• Associate II’s responsibilities include, but are not limited to testing pH, Appearance, Osmolality, Protein Concentration (UV, RI, and SoloVPE).


• The Associate II should possess a fundamental understanding of the Client Quality Systems and apply it in their daily support functions.


• Additional responsibilities include ensuring adherence to all GLP/GMP requirements, interfacing with Quality and manufacturing as applicable.


• Supporting investigations impacting the QC department.


• The Associate II should be able to work effectively within the group, within Quality and across site.


• This requires solid and robust written and verbal communication skills.


• Performs in-process, release testing, method transfer and validation support activities/testing.


• Supports investigational activities including testing. - 85%.


• Supports QC Biochemistry operations related to business and manufacturing schedules, support of process validation initiatives. - 10%.


• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results. - 5%.

Skills:

Quality ControlBiochemistry TestingIn-Process TestingRelease TestingMethod TransferValidation TestingGLP/GMP CompliancepH TestingAppearance TestingOsmolality TestingProtein Concentration Testing (UV, RI, SoloVPE)Quality SystemsInvestigation SupportLaboratory SystemsWritten and Verbal Communication

Education/Experience:

B.S. Degree (Science Preferred).2+ years of relevant experience (M.S. degree) or 3+ years of relevant experience (B.S. degree).