Quality Assurance/Document Control Technician (TEMP/CONTRACT)

Arcturus Therapeutics Inc

New Hired from Arcturus Therapeutics Inc

Job Description:

If this job matches your qualifications, please send your application directly through our latest Job site in San Diego, CA
(Torrey Pines area). Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Arcturus Therapeutics Inc who are looking for potential candidates to work. Good job information Quality Assurance/Document Control Technician (TEMP/CONTRACT) below matches your qualifications.

WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global, late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis, along with partnered programs including glycogen storage disease type III, and hepatitis B virus. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation.

Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.

THE OPPORTUNITY

The QA/DC Technician for the QA/DC team offers the opportunity to support processes which may include document control, training, non-conformances, CAPA, supplier management, internal auditing, process validation or design control, and risk management.

WHAT YOU WILL CONTRIBUTE

  • Support the creation and review of regulated documents associated with the design and manufacture of products such as SOPs, specifications, testing protocols and reports, quality control and reliability plans etc.
  • Review in-process and final product specifications to evaluate and set quality requirements.
  • Participate in development and implementing methods and procedures for inspecting, testing and evaluating raw materials, components and finished products.
  • Perform analysis of production and process data to address nonconformities, identify trends and recommend improvements to processes and procedures to reduce and control manufacturing process defects.
  • Provide support on the development of verification and validation plans, test and sampling methods, sample size determination and acceptance criteria.
  • Provide quality perspective in support of design control and change control activities
  • Support tasks related to cross-functional teams for new product development, quality & cost improvement.
  • Provide support on the assessment and disposition of nonconforming material.
  • Provide support on CAPA investigations and effectiveness assessments.
  • Regularly interacts with other departments and suppliers regarding quality matters.
  • Provide staff training on regulatory requirements, specializing in testing methods, or manufacturing improvement.
  • Assists in the completion of routine and non-routine tasks; assists in the analysis, investigation and solution of problems; and assists in developing electronic and hard copy documentation as required
  • Under general supervision, working on routine projects with general instruction and non-routine projects with detailed instructions
  • Participates in the day to day activities of assigned functional area assisting in the completion of routine and non-routine tasks
  • Assists in applying knowledge to analyze, investigate and resolve problems
  • Assists in developing electronic and hard copy reports, records, diagrams and charts
  • Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company
  • Expected to work in a safe manner in accordance with established operating procedures and practices

WHAT WE SEEK

Position Requirements:

Education Required:

  • High school diploma/G.E.D required, Associate’s or technical degree preferred

Experience Required:

  • 2-5 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable on-site attendance

Specialized or Technical Knowledge, Licenses, Certifications needed:

  • Detail-oriented with strong analytical, written, verbal communication and interpersonal skills.
  • Experience with Veeva Vault, Master Control or similar Electronic Data Management Systems preferred.
  • Background in Good Documentation Practices. Must be computer-literate.
  • Ability to work well under pressure, independently, to multi-task, and have good time management skills
  • Competencies: Please list areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others like it.
  • Planning & Organizational
  • Ability to think critically and creatively; have great attention to details.
  • Have strong organizational and planning skills.
  • Able to work independently and collectively as part of an integrated team environment with extensive interactions with.
  • Comfortable working in a highly innovative environment and strong ability to cope with change.
  • Plans periodic review of SOPs and other procedural documents using a risk-based approach.
  • Assesses gaps in existing SOPs; plans updates and implementation in accordance with applicable regulatory requirements and corporate goals
  • Develops workable action plans for streamlining and implementation of activities, thereby reducing cycle time and increasing efficiency. Interpersonal
  • Must be very meticulous, well-organized and pays attention to detail.
  • Excellent communication and interpersonal skills.
  • Must be friendly, hard-working, and enjoy working in a fast-paced environment. Must be able to work with changing priorities. Sets expectations and monitors delegated activities.
  • Treats people with respect. Honors and shows respect and sensitivity for cultural differences and diversity.
  • Keeps commitments; works with integrity and ethically; upholds organizational values.
  • Interpersonal
  • Excellent communication skills when communicating with management, colleagues, peers, and management of other departments, third parties, and regulatory agencies.
  • Must be friendly and possess good interpersonal skills. Sets expectations and monitors delegated activities.
  • Shows respect and sensitivity for cultural differences.
  • Treats people with respect; keeps commitments; works ethically and with integrity; upholds organizational values.
  • Must be a team player.
  • Communication
  • Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions.
  • Excellent verbal and written communication skills. Writes clearly and informatively; edits work for spelling and grammar; presents numerical data effectively; able to read and interpret written information.
  • Capable of communicating effectively in English with all departments, management, third party contractors, and auditors.
  • Maintains confidentiality; remains open to other’s ideas and tries new things.
  • Communicates changes and progress; completes projects on time and within budget.
  • Autonomy and Independence
  • Assesses own strengths and weaknesses; strives to continuously build knowledge and skills.
  • Interacts with all team members as needed and can work independently with little supervision.
  • Synthesizes complex or diverse information; designs workflows and procedures; gathers and analyzes information skillfully.

EDUCATION

  • High school diploma/G.E.D required, Associate’s or technical degree preferred.

WHAT WE OFFER

An exciting opportunity to join a company that offers:

  • Catered lunches
  • Free variety of snacks and beverages
  • Referral Bonuses
  • On Campus Gym
  • Company sponsored FUN events

The anticipated salary range for candidates who will work in San Diego is $15.50 to $18.00 per hour.

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Arcturus Therapeutics is multi state employer and this salary range may not reflect positions that work in other states. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com

Arcturus 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.

How To Apply :

After reading and knowing the criteria and minimum qualification requirements that have been explained from the job info Quality Assurance/Document Control Technician (TEMP/CONTRACT) in the office San Diego, CA
(Torrey Pines area) above, then the jobseeker who feels that he has not met requirements include education, age, etc. and are really interested in the latest job vacancy Temporary above, it should be as soon as possible to complete and compile a job application file such as a job application letter, CV or curriculum vitae and transcripts and other complements as described above, in order to register and participate in the admission selection for new employees at the company in question, sent via the link below.

Other Information :

  • Country : US

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