Researcher / analyst
days alert frequency in every certain daysShare this Job Quality Analyst II
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a qualified individual who will be responsible for performing/overseeing a wide variety of molecular, cell biology, and chemical analytical methods required to support in-process, final product and stability studies for Process Development (PD), Technical Transfer (TT), Manufacturing (MFG), and external clients. The candidate will be responsible for ensuring compliance with the established SOPs, cGMP, and all regulatory agencies. He/she will need to embody the company vision and values.
This individual will be contributing to our Biology and Biochemistry teams efforts in raw material qualification and testing, stability testing and in-process testing associated with the production of our products. The candidate must possess a moderate understanding of the pharmaceutical development processes from pre-clinical development through the life-cycle management as well as clean room flows and aseptic techniques. The selected candidate will be fully engaged with cross-functional teams seeking to support new analytical assay development to support and enhance company’s assay platforms.
As a Quality Analyst II, candidate will support the comprehensive quality metrics, including tracking and trending performance by Key Performance Indicators (KPIs), managing timelines and working with various stakeholders to successfully deliver customer deliverables, while helping to maintain our production environment in a state of audit readiness.
This role will also be one of the key personnel for the Biochemistry and Biology lab teams for the site. He or she will be primary expert in training to provide technical advice and support for internal and external interactions during client and regulatory audits/inspections, meetings, and teleconferences. The role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships, including both internal and external stakeholders.
Supports the daily operations of the Biochemistry, Biology, Manufacturing, Technical Operations and Process Development groups.
Responsible for performing a wide variety of analytical testing methods including but not limited to raw material testing and microbiology assays.
Ensure testing compliance with ISO, FDA, cGMP, EMA and MilliporeSigma requirements.
Performs analysis and interpretation of data along with data management, tracking and trending
Contributes ideas and suggestions to optimize and improve standard laboratory techniques, protocols processes, and equipment.
Operates and maintains lab equipment as required by SOPs and testing procedures
Responsible for initiating, investigating, resolving and completing event records within our controlled event system TRACKWISE.
Liase with Quality Assurance (QA) and other cross-functional departmental areas to close the events or corrective actions identified during GMP laboratory testing.
Create/Revise SOPs, laboratory records and other related documentation. Ensure that all required documentation including records and log books, is complete and accurate according to the current SOPs and regulatory guidance.
Promotes a culture of continuous improvement within MDQC; act as champion on initiates and/or projects to drive improvement in quality and/or client service (internal or external).
Comports with Merck corporate competencies: Purposeful, Future-oriented, Innovative, Results-driven, Collaborative, Empowering.
Complies with company health and safety regulation and procedures
Supports work activities as assigned to satisfy quality objectives.
Prepare/ review protocols and final reports as needed.
Prioritize tasks to ensure that projects are completed by deadlines and streamlining processes to maximize productivity.
Provide technical support for internal and external interactions, such as client and regulatory audits/inspections, meetings, teleconferences.
Support the team building by participating in recruiting, interviewing, hiring, and mentoring new talent.
This role will require; intermediate skills in applicable computer programs, excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc. Excellent time management, project management and people skills as well as highly collaborative as well as independent individual contributor, the ability to demonstrates a high level of initiative of starting new projects/assignment, the ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities are also required within this role. You will need to have a proven ability to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity, have excellent communication, organization, analytical and technical writing skills, have working knowledge of validations, calibration systems, process design, design of experiment, instrumentation, automation, and digitization/paperless system. Additionally you will also need; operational knowledge of the regulation (cGMP, ISO, EMA) and directives, and liability for non-compliance, possess understanding of group dynamics and have the ability to effectively influence group decision-making process, the ability to analyze past and current data and recommend objectives to improve productivity and increase efficiency, as well as working knowledge of method development, qualification and validation and method transfer principals.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties, the employee is:
Constantly required to sit and reach to use computers and other office/lab equipment
Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
Occasionally required to lift up to fifty (50) pounds
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee,
- Bachelors in Life Science discipline with 2+ years of analytical experience OR Master’s in Life Science discipline with 1+ year of analytical experience
- 2+ years of experience in Quality Control and CMO environment
- Experience with cGMP, aseptic techniques, relevant working knowledge and experience in microbiology and raw material testing (i.e. pH, Endotoxin, Bioburden, Osmolality, TOC and conductivity testing)
- Knowledge in Lean Manufacturing and Continuous Improvement.
- Good understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals as well as compendial methods.
Working time model: full-time
US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.