Senior Analyst, Laboratory Quality Control

AbbVie; Irvine; On-site; GBP 60,000 - 80,000; Full time

Job summary

A biopharmaceutical company in the UK is seeking a laboratory technician to perform quality tests on materials and products. This role involves microbiological and analytical testing, ensuring adherence to regulations and quality control. Candidates should have relevant educational backgrounds in science along with practical laboratory experience. The position supports various projects and requires effective communication skills. Comprehensive benefits and a competitive salary are offered, with potential for incentive programs.

Benefits

Paid time off

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• Associate degree in science and five years of relevant experience; or bachelor’s degree and three years of lab experience.
• Experience in microbial and analytical testing/methodology.
• Basic knowledge of computer systems and lab techniques.

Responsibilities

• Perform quality lab testing for manufacturing processes.
• Conduct microbiological and analytical testing such as endotoxin and bio burden.
• Maintain lab data integrity and adhere to regulations.

Skills

Microbial testing

Analytical testing

Communication skills

Laboratory techniques

Education

Associate's degree in Biology, Chemistry, Microbiology or Medical Technology

Bachelor's degree in Biology, Microbiology or Chemistry

Tools

HPLC

Gel Electrophoresis

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.

Job Description

Performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in process samples and final product following specifications in both the microbiological and analytical laboratories. Performs microbiological and analytical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product. Performs in process product testing such as bio burden, and endotoxin and analytical testing (HPLC, Gel Electrophoresis, DNA), among others. Performs other microbiological lab testing such as growth promotion and identification of microorganisms. Provides support in method transfer, equipment/instrument qualification and process validation.

• Understand Regulations and business processes required to maintain Laboratory Data Integrity.
• Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
• Adhere to cGMP requirements.
• Adhere to and supports all EHS & E standards, procedures and policies.
• Responsible for the timely completion of assigned laboratory testing.
• Ensure that all test equipment is used and maintained correctly.
• Able to work independently.
• Perform environmental monitoring in cleanrooms within the manufacturing area.
• Collect water samples throughout the manufacturing facility and test for bioburden and endotoxin.
• Perform bioburden and endotoxin for final drug substance.
• Knowledge in general microbiology preferred (Gram-stain, spore stain, streaking, growth promotion…).
• Able to work in an environment where respirator is required to be worn during production for at least 4 hours.
• Position requires constant body movement such as lifting, carrying equipment during environmental monitoring, pushing carts, doors.
• Able to accommodate weekend and holiday work as required by the manufacturing schedule.
• Participate in method transfers and validations as needed.
• Authoring and review of documents such as protocols, reports, test methods, SOPs.
• Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results.
• Support the qualifications of new laboratory equipment.
• Responsible for daily activities such as waste disposal, glasswasher, autoclave runs.
• Able to maintain accurate inventory records of toxin during usage.

Furthermore, the position requires the individual to work with and in areas requiring select agents (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. Employment is contingent upon CDC and FBI clearance.

Qualifications

• Associate degree in science (major in Biology, Chemistry, Microbiology or Medical Technology) and five (5) years of relevant experience; or bachelor’s degree in science (major in Biology, Microbiology or Chemistry), and three (3) years of relevant laboratory experience.
• Experience in the general microbial and analytical testing/methodology (e. g. endotoxin, bio burden, HPLC, Gel Electrophoresis).
• Basic knowledge of laboratory techniques and laboratory instruments.
• Basic knowledge of computerized systems.
• Basic verbal and written communication skills in English.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html