Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
Work with internal and external resources to maintain lab in an optimal state.
Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
Maintains laboratory instruments for calibration and routine maintenance
Author or revise SOPs, qualification/validation protocols and reports.
Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
Provide updates at daily and weekly meetings.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Gather metric information for use in continuous improvement of areas of responsibility.
Perform other duties as required.
Basic Qualifications
Bachelor’s Degree OR
AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR
High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience
Preferred Qualifications
Strong knowledge of GMP, SOPs and quality control processes.
Identifying, writing, evaluating, and closing OOS’s and investigations.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel.
Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
Preferred: Experience in the biotech and/or pharmaceutical industry.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at ICONMA by 2x