Document Control Specialist

Cutera Brisbane , CA 94005

Posted 1 week ago

Company Description

About Us: Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right person to help grow our business and reap the rewards of doing it! We hire the best people and provide them the best comp and benefits to help improve their lives. Read more at

Job Description

Position Summary:

  • Responsible for the administration of the document and training management systems

  • 'Gatekeeper' for the Cutera document control system

  • Foster a strong 'right first time' compliance culture

  • Be solutions oriented and a business partner for QMS Enterprise software

Duties and Responsibilities:

  • Manage the development and maintenance of document control and learning management systems at Cutera

  • Administer Arena PLM system including maintenance of user accounts and configuration management

  • Work with functional management to develop and maintain employee training plans

  • Identify and evaluate systems for training that utilize current industry best practice to provide a user-friendly, cost-effective system that meet business and regulatory requirements

  • Perform user training on the document management system, electronic signature workflow and document control processes

  • Publish reports on employee training status and develop plans for improving completion

  • Manage the document change process for the submission, routing, review, approval, publishing and archiving of Cutera quality system documents

  • Ensure revision and change control is maintained, documents are entered correctly and follow Cutera, FDA quality system regulation, ISO 13485, EU MDR requirements

  • Manage master lists and files for product DHF, DMR and DHRs

  • Develop and manage plan to transition remaining legacy paper-based system into the Cutera electronic document management system (eDMS)

  • Develop templates; ensure only the approved document templates are used for creating, updating quality system documents

  • Withdraw obsolete and superseded documents from circulation and prevent use thereof

  • Provide timely documentation and assistance during audits and inspections

  • Provide reports to management on the performance of the document management process against agreed KPIs, as well as making recommendations to ensure continuing effectiveness

  • Other duties as assigned


  • Document control experience in a regulated industry required

  • Associate's/Bachelor's degree in technical or business management related field preferred

  • 5 to 7 years of related QA experience required

  • Experience with Arena Solutions PLM system would be an advantage

  • Ability to work with all levels of organization in a fast-paced environment

  • Strong written and verbal communication

  • High attention to detail

  • Proficiency in MS Windows Word, Excel and PowerPoint

Additional Information

All your information will be kept confidential according to EEO guidelines.

If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Specialist Quality Control Cell Culture And Bioassay

Sangamo Biosciences, Inc.

Posted 3 months ago

VIEW JOBS 5/27/2022 12:00:00 AM 2022-08-25T00:00 Manager: Associate Director, Quality Control Analytical Department: Technical Operations - Quality Control Location: Brisbane Sangamo Therapeutics is a genomic medicines company that is building value by developing cutting-edge therapeutics utilizing distinct but complementary genome editing and gene regulating platforms. At Sangamo, we are passionate about developing genomic medicines that will transform the lives of patients with serious, life-limiting diseases by aggressively developing and delivering our innovative, high value genomic medicines pipeline. Sangamo takes pride in being the first company to edit endogenous human genes, the first company to treat patients with gene edited T cells, and the first company to treat patients using targeted in-vivo genome editing therapeutics. Our top priority is to meet the needs of patients with commitment and compassion. Sangamo is a company where individuals can flourish, grow, and develop their expertise. We are seeking top talent to join our team. Let's build a better future together. JOB SUMMARY: We are seeking a talented and highly motivated Specialist to join our QC - Cell Culture and Bioassay group. The Specialist will be tasked to perform GMP QC testing on manufacturing intermediates and released drug products in support of our internal and external cell and gene therapy manufacturing operations. Products to be tested include, but are not limited to, recombinant viral vectors (AAV and lentivirus), ex-vivo gene-modified T cells, and gene editing mRNAs. The QC Specialist will be responsible for routine testing, assay transfer and assay validation, QC document preparation and revision (SOPs/Protocols/Reports), laboratory investigations, and laboratory setup and maintenance. ESSENTIAL FUNCTIONS: * Responsible for routine QC testing, data review, and preparation of summary reports. Testing will focus on cell-based assays for cell and gene therapy products (Infectious titer assays, Relative potency assays, Colony Forming Assays etc.) * Responsible for maintaining a variety of cell lines in culture (mammalian and insect). * Participates in inspection readiness activities. May represent QC during audits by regulatory agencies. * Understands USP/EP requirements for product release testing and analytical method validation and transfer. * Assist with equipment qualification and/or validation activities: drafting and executing IOQ protocols, drafting and reviewing reports and other documentation. * Responsible for conducting and/or assisting with laboratory investigations: deviations, OOS/OOT, aberrant/unexpected results, and invalid results. * Responsible for conducting and/or assisting with the identification, initiation, and closure of quality events (Deviations and CAPAs) related to cell culture and bioassay testing. * Responsible for keeping accurate and complete records (test records and laboratory notebooks) per cGMPs. EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: The ideal candidate for this position will have demonstratable knowledge and understanding of QC functions associated with the testing of ATMP manufacturing intermediates and final drug products in an industry setting. The successful candidate must: * Possess, at minimum, a BS degree in the Life Sciences (Molecular and Cellular Biology, Biochemistry, or a related field). Course work in immunology, virology and cell biology is a plus. * Have 2-5 years of quality control experience in a QC laboratory setting. Experience working in the ATMP (Advanced Therapeutic Medicinal Products Field - Cell and Gene Therapy) is a plus. * Have hands-on experience with mammalian cell culture and aseptic handling of test articles. * Have experience and/or knowledge of classical virology techniques: i.e., plaque assays, tissue culture infectious dose assays (TCID50), focus forming assays, heme agglutination - heme adsorbing assays, and replication competent virus assays. * Have experience and/or knowledge of analytical method qualification/validation, and transfer in accordance with USP/EP guidelines. * Regularly apply theories and principles from one's technical / professional discipline to independently address a variety of problems of moderate to difficult scope * Must have ability to work both independently and in a team-oriented environment with minimal supervision. * Must be able to identify and report OOS/OOT/aberrant lab results to manager and conduct or assist in laboratory investigations. OTHER REQUIREMENTS: * The successful candidate will possess excellent oral communication skills. * The successful candidate should possess strong interpersonal skills with the capability to establish and maintain collaborative working relationships within QC, and with members of the Analytical Method Development, Manufacturing, and QA teams. * The successful candidate will have the ability to operate in a fast-paced, multi-disciplinary industrial environment. * The successful candidate must have a flexible work schedule. This is a first shift M-F position, but occasional evening or weekend hours may be required. Sangamo is an equal opportunity employer The above reflects management's definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time. Commitment to Safety Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws. Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part. If you wish to be considered for the presentation of candidates, please contact us through Sangamo Biosciences, Inc. Brisbane CA

Document Control Specialist