Quality Control Associate I

Position Details: 

Client Direct Client

Location Research Triangle Park, NC

Job Title Quality Control Associate I

Duration 1 Year+

Must have skill-set [Job Description] Job Summary:

The Quality Control Associate I is responsible for supporting key functional, tactical, and operational aspects of the Quality Control Chemistry group .

Responsibilities:

• This includes performing QC Raw Material sampling and testing as well as all activities associated with this sampling and testing.

• The Associate I responsibilities include, but are not limited to sampling, training, testing support for raw materials, support for transfer qualification and validation activities as appropriate, robust and compliant cGMP documentation practices, and providing sound technical support as a subject matter expert in one or more key functional areas. 

• Process all associated documentation and computer system entries. 

• Has a fundamental understanding of the Quality Systems and apply it in their daily support functions. 

• Additional responsibilities include adherence to all GLP/GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations impacting the QC Chemistry department. 

• The Associate I may also support the Supervisor/Manager for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective actions on the floor. 

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

• This requires solid written and verbal communication skills. 

• The Associate I should actively seek to understand their personal leadership approach and communication style. 

• Weekend and overtime work may be required.

Additional Information/Requirements: 

The Quality Control Associate I will possess technical knowledge regarding Quality Control Chemistry release and stability methodology. The position requires but is not limited to the following: 

• Bachelor’s degree in Chemistry or equivalent discipline with 1 – 2 years, OR Associate degree or High School Diploma with appropriate equivalent experience (Typically 3 + years) 

• Knowledge and limited use/application of basic scientific theory and principles. 

• Able to apply basic understanding of scientific data/literature to conduct experiments 

• Knowledge of commonly used laboratory instrumentation (HPLC, GC, UV-vis, Dissolution, and FT-IR) and software 

• Knowledge of cGMP/cGLP requirements and laboratory safety

• Computer literacy 

• Lifts and carries laboratory solvents/supplies up to 10-20 pounds

• Remains standing/on feet for extended durations throughout day

• Exposure to chemicals, dust, fumes, odor, and hazardous lab waste

• Weekend and overtime work may be required

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