QC Analyst III - biotech/pharmaceutical/medical device

Position: QC Analyst III


This is a temporary position lasting 6+ months with possibility of hire.


Note: REQUIRED skills and experience: HPLC Analytical Experience, QC Testing Experience and GMP knowledge. Any Science Degree will be accepted but a Chemistry Degree is highly preferred.



Job Description

 

Summary: Oversees and evaluates all processes leading to the accurate and reliable generation of data for a biologic product or medical device.

 

Essential Duties and Responsibilities

Oversees and performs prescribed testing for product release in accordance with established procedures.

Oversees and performs prescribed procedures, sample collections, customer complaint testing, stability and performance testing to monitor adherence to quality control specifications.

Participates in the implementation and execution of validation studies on performance assays and analytic instrumentation to ensure consistency of data production and concurrence with manufacturer and national standard reference values.

Participates in the design and implementation of stability protocols, performs statistical analyses, and assists in the review of stability protocols and final packages.

Designs databases for entry of data in regards to data evaluation.

Serves as liaison/team member with QA, regulatory affairs, research and development, and manufacturing departments for routine issues.

Participates in the transfer of new products/methods.

Trains new employees and coworkers as assigned by supervisor/laboratory coordinator.

Assists in developing lab documents to support laboratory compliance with Good Manufacturing Practice (GMP), and documents method and validation development.

Performs other related duties as assigned.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

Bachelor's degree or equivalent in Chemistry, Biology, Microbiology or related field

Three years related experience and/or training; or equivalent combination of education and experience.

Certified Quality Technician desirable.

Prior laboratory experience required.

Knowledge of GMP/GLP required.