SRG, the leader in the Life Sciences human capital industry, is looking for a contract QC Analyst II based in PA. The QC Analyst II will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical bio-pharmaceutical products and by participating in assay qualification and validation studies

JOB RESPONSIBILITIES include, but are not limited to:

• Bio-pharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger, phase 3 campaigns, while stability studies cost several hundred thousand dollars each, and this individual has an important role in ensuring that release and stability testing generates accurate results, without delays or compliance issues.

• The individual will help maintain the biochemistry laboratory systems, assist in training other analysts, help maintain SOPs and other documents, and promote an orderly and efficient laboratory workplace.

WHAT YOU NEED TO HAVE:

• Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
• Knowledge of principles, concepts, and practices in QC testing of protein bio-pharmaceuticals.
• Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of recombinant proteins.
• Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
• Ability to identify and help investigate assay and equipment problems.
• Fluent in English, good written communication skills; good interpersonal skills.
• Team player who can excel in a "hands-on" entrepreneurial environment.
• Physical requirements: handling of laboratory equipment, chemicals, and biological materials

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.