Quality Control Anaylst

Quality Control Anaylst

Job Summary:
Beyond a Resume is seeking a highly motivated QC Analyst with an entrepreneurial spirit for a position to support our biopharmaceutical development programs.

We are looking for highly qualified QC Analyst with a bachelor with two to five years experience supporting GMP QC Laboratories . The level of this position will be commensurate with candidate’s work experience.

Responsibilities

-Execute Raw Material, Drug Substance and Drug Product release and stability testing in support of Phase I, II, III and commercial manufacturing of biotechnology products

Draft and execute Method Validation Protocols

-Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms

-Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release

-Write or revise Standard Operating Procedures, Work Instructions, Standard Test Methods and Forms

-Generate Method Validation and Deviation/Out of Specification reports, Change Control requests and CAPAs

-Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols

-Train other analysts to perform laboratory procedures and assays

-Serve as a technical liaison between quality control and other departments, vendors, or contractors.

-Participate in functional teams with various experience levels and provide input as needed on assay’s issues.

-Supply quality control data necessary for regulatory submissions.

-Evaluate new technologies and methods to make recommendations regarding their use

-Ensure that lab cleanliness and safety standards are maintained

-Identify and troubleshoot equipment problems

-Evaluate analytical methods and procedures to determine how they might be improved

-Support QC laboratory inspection readiness strategy and activities

This is an excellent opportunity to gain valuable experience with an innovative and growing Biotech company and build a career in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential, high reward environment and be able to work flexible hours, including weekends, as project needs are determined.

Job Qualifications:

-BS degree and 2 to 5+ years’ experience supporting GMP QC Laboratories

-Experience in biologic’s intermediate, release and stability testing

-Understanding of regulations governing documentation, data collection and data integrity

-Strong communication skills: oral/written and listening. Ability to effectively communicate

(orally and written) with all levels of personnel

-Ability to work individually and in a team environment

-Ability to work under pressure and analyze processes within scheduled timeframes

-Ability to prioritize and manage tasks and operational flexibility

-Experience in Technical Writing

-Hands on experience with CE and HPLC instrumentation highly preferred

-Hands on experience in one or more of the following assays: ELISA, SEC-HPLC, RP-HPLC,

CGE/cIEF, SDS-PAGE, A280, Endotoxin and Cell Culture Based Assays

-Proficiency with Microsoft Office (Word, Excel and Powerpoint etc.)

Job Type: Full-time

Salary: $90,000.00 – $110,000.00 per year

Benefits:

  • 401(k)
  • Health insurance
  • Paid time off

Schedule: Monday to Friday (some weekend work)

Work Location: Frederick, Maryland

To apply for this job email your details to eddie.ohanian@beyondresumes.net