Quality Control Senior Specialist, Contract Job at Vertex Pharmaceuticals
Job Description
This role provides a variety of analytical functions that occur in the QC environmental monitoring and utilities monitoring (EM/UM) laboratory supporting oral dose and cell therapy GMP manufacturing facilities. Specific assigned persons are responsible for hands-on environmental monitoring and utilities sampling, testing, and reporting while ensuring activities occur in an efficient and cGMP compliant manner fostering the Vertex vision and values.
KEY RESPONSIBILITIES:
- Collect, transport and process environmental monitoring of air, surface, personnel gowning, water, gas and steam systems samples according to established schedules or as requested with minimal supervision.
- Perform microbiological (Bioburden, growth promotion, etc.) and chemical assays (Endotoxin, Total Organic Carbon, Conductivity, and Nitrates), related to clean room monitoring, utility monitoring independently following established methodology, procedures, and SOPs.
- Analyze organisms on cultured media from environmental monitoring and utility samples
- Maintain accurate sampling and testing records and adhere to cGMP/GDP expectations
- Report OOT/OOS results and other deviations to area management.
- Review independently following established methodology, procedures, and SOPs
- Assist in troubleshooting of analytical microbiological and chemical methods with the assistance of supervisor when necessary
- Participate in executing method validations and/or classified areas qualifications.
- May participates in author and review data, procedures, microbiological and chemical analytical methods, protocols, reports, deviations, and other quality records.
- May participate in compliance related teams working towards the goal of continuous improvement.
- May perform maintenance of instrument/ equipment calibration, temperature monitoring, reagent preparation, material and supply ordering and other general lab related responsibilities, as needed.
- Assists in everyday organization of the EM/UM laboratory including safety, cleaning, maintenance and ordering of supplies.
- May provide environmental monitoring and utilities monitoring guidance for training to junior staff or other departments.
- Perform other laboratory duties as assigned.
REQUIRED EDUCATION LEVEL:
- A minimum of a bachelor’s degree in science (i.e., microbiology or related discipline) is required.
REQUIRED EXPERIENCE:
- For a QC Sr specialist - A minimum of 5 years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred).
- For a QC specialist - A minimum of 3 years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred).
- For a QC Associate /Analyst - A minimum of 2 years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred).
REQUIRED KNOWLEDGE/SKILLS:
- Understand cGMP concepts and general practices.
- Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection.
- Knowledge of various laboratory equipment including Microbial ID systems, Chemical Analysis, pH meter, and balance. etc.
- The ability to work well on a team in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.
- Strong attention to detail, proactive, action oriented and can rapidly adapt to a change
- Demonstrate good communication skills, both verbal and written, at all levels and across various functions.
- Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results
- Ability to work weekends and off-shift hours, as needed.
- This is a weekly second shift role 1-9:30pm (40 hrs /wk). A work week alternative of 4 days shifts (10hrs), Wed-Sat/ 1-11pm or Sun-Wed/ 1-11pm is also available upon agreement.
This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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