Quality Control Molecular Scientist - ELISA
Quality Control Molecular Scientist - ELISA
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Job Description
General Description:
Perform testing in support of product manufacturing employing manual and automated analytical equipment. Provide direct support of Quality Control analytical processes test procedures qualifications validations assay troubleshooting equipment upkeep logbook review and inventory control.
Job Responsibilities:
- Execute Analytical Test Methods for inprocess samples bulk intermediate (drug substance) final drug product and raw materials release as well as stability testing.
- Primary testing responsibility will be conducting ELISA testing to support assays such as Residual p24 COL7/Lam332 BSA and Trypsin assays. However crosstraining in cell culture and other analytical methods will be required (e.g. qPCR flow cytometry platforms).
- Coordinate schedule and execute testing based on manufacturing schedules.
- Participate in the review process of SOPs and analytical test procedures as necessary to maintain compliance.
- Review Quality Control raw data for accuracy completeness and compliance with effective SOPs to ensure the strength identity safety purity and quality of the product.
- Troubleshoot and analyze nonconforming data.
- Perform timely response to Out of Specification (OOS) results including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified impact assessed and actions to prevent recurrence are considered and implemented. Execute associated CAPA.
- Ensure data integrity is maintained for all applications programs and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.
- Maintain laboratory housekeeping including organization cleanliness and logbooks.
- Perform internal audits and GEMBA walkthroughs of laboratory areas to maintain compliance.
- Author and/or execute protocols and generate technical reports.
- Author and manage change controls.
- Perform equipment standardizations and qualification as necessary.
- Perform training of other employees.
- Communicate with the individual Operations Departments (Manufacturing Quality Assurance Facilities) to ensure that Company objectives are met on schedule.
Qualifications :
Basic Minimum Qualifications:
- BS in Biochemistry chemistry or similar scientific discipline
- 2 years Quality Control experience in GMP environment specifically working on ELISA methodology in a similar role in the biologics industry. Academic experience does not count towards this.
- 2 years experience in mammalian cell culture in an academic or industrial laboratory
- Knowledge of basic laboratory skills (including aseptic technique pipetting biohazard control)
- 1 years GMP/GDP experience in an industry setting
- Familiarity with analytical equipment such as UV absorbance plate readers Flow cytometers microscopes and pH meters is recommended.
- Excellent verbal and written skills with good interpersonal communication skills
- Must be open to occasional off shift and weekend work
- Must be eligible to work in the United States indefinitely without sponsorship.
Additional Information :
Position is Full Time First Shift some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Exton PA are encouraged to apply.
What we offer:
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goalbased bonus & eligibility for meritbased increases
Eurofins USA PSS Insourcing Solutions is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
