Posiition Summary
Quality Control (QC) Microbiologist for the purification and aseptic manufacturing plant at Grifols Worldwide Operations (GWWO), reporting to the QC Microbiology Manager.
This role offers a chance to work in a state-of-the-art facility, in an innovative biotechnology company with excellent career development opportunities and a clear and committed patient focus.
What you'll do
Purified water, water for injection and clean steam microbiological bioburden (TVC) and endotoxin (LAL) analysis.
Additional analytical testing as required.
Carry out environmental monitoring, including viable/non-viable particle monitoring in manufacturing facilities as required.
Carry out in-process and finished product microbiology analysis including total viable count (TVC), microbial ID, sterility and endotoxin testing as required.
Ensure laboratory processes, equipment and services are installed, qualified and maintained appropriately.
Participate in the verification, validation and technical transfer of microbiological and analytical testing procedures.
Ensure that all cGMP and company specifications and procedures are followed.
Investigate out-of-specification (OOS) and out-of-trend (OOT) results as required.
Participate in and be responsible for QC-related CAPAs.
Adhere to the QC documentation system and prepare and review document change requests as required.
Develop, improve and implement QC procedures, processes and systems.
Support projects and continuous improvement initiatives within the Quality department and other functional areas.
Participate in international project teams relating to QC and wider quality activities; travel may be required.
Adhere to safety standards to ensure a safe working environment while keeping the laboratory clean, tidy and safe at all times.
Prepare for and support regulatory and internal inspections/audits.
Provide hands-on guidance and training when needed.
Ensure the work area is maintained in a state of compliance and audit readiness.
Flexibility and willingness to carry out shift work when required.
What you'll bring
Knowledge of and proficiency in a wide array of current microbiological techniques.
Knowledge of and proficiency in the use of analytical instruments.
Experience with investigating and determining the root cause of out-of-specification and out-of-trend results.
Excellent verbal and written communication.
Must be able to read, write and speak English.
Strong interpersonal skills with the ability to interact with all levels of personnel in a professional manner.
Strong organizational, analytical and problem-solving skills.
Knowledge of sterility failure investigation desirable.
Experience with SAP desirable.
Experience in method transfer and verification/validation desirable.
Knowledge of analytical techniques for biologics or protein-based therapeutics desirable but not essential.
Qualifications
Bachelor's degree in microbiology, biochemistry or a closely related scientific field.
Requires a minimum of 2 years of related experience.
Our Benefits Include
Highly competitive salary.
Group pension scheme – contribution rates are (3%/5%/7%) and the company will match.
Private medical insurance for the employee.
Ongoing opportunities for career development in a rapidly expanding work environment.
Succession planning and internal promotions.
Wellness activities – social activities such as padel and summer events.
We understand that self-doubt can hold talented individuals back from applying for opportunities.
We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
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