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Regulatory Compliance Expert

2 months ago

Camarillo, California, United States SaniSure LLC Full time
Job Description

About SaniSure LLC

SaniSure LLC is a multinational manufacturer of single-use bioprocessing solutions used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines.

Our Growth Trajectory

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our Portfolio

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

Our Culture

SaniSure LLC is a high-growth, nimble and innovative company with a strong customer and market focus. We are committed to delivering high-quality products and services to our customers.

Job Summary

We are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for collaborating with stakeholders to manage the Quality Management System, recommending and implementing changes to the existing quality system, and ensuring compliance with applicable regulatory requirements.

Key Responsibilities

  • Perform all activities involving quality assurance and compliance with applicable regulatory requirements.
  • Prepare regulatory submissions and compliance with applicable national and international regulations.
  • Conduct audits and review/analyze data and documentation.
  • Manage internal audit program and support QMS related activities.
  • Host customer audits.
  • Perform supplier audits and support supplier audit programs.
  • Initiate, investigate and complete corrective actions (CA).
  • Participate in MRB meetings and provide input on problem solving tools and methods to coordinate and/or lead investigation teams.
  • Initiate, investigate and complete change notifications.
  • Participate in the management and execution of equipment, processes, and software validation.
  • Manage the equipment calibration and maintenance program.
  • Provide directions for all aspects of testing related to manufacturing:
    • First article inspections,
    • In-process release inspection,
    • Final QC release of finished goods, and
    • Document review.
  • Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
  • Perform environmental monitoring of cleanrooms and bioburden results and provide solutions for microbial failures.
  • Assist department with continuous improvements initiatives or lean projects.
  • Act as Quality Assurance representative on facility projects, as needed.
  • Respond to customer complaints and collaborate with internal departments for resolution and preventative corrective actions.
  • Other duties as assigned by manager.

Requirements

  • Bachelor's degree in Business, Sciences or Engineering
  • 5+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility.
  • Strong understanding of global pharmaceutical and biotechnology product regulations with proven experience with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
  • 5+ years of experience with technical documentation for complex activities in the areas of the Quality System that includes corrective actions, change control, quality audits and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.
  • Excellent customer service skills.
  • Familiar with a variety of field concepts, practices, and procedures as SPC analysis. Relies on experience and judgment to plan and accomplish goals.
  • Solid organizational and planning skills.
  • Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
  • Must be able to work effectively and efficiently in a team environment.
  • Proficient problem-solving skills using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.
  • Demonstrated proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision-making skills utilizing risk management.
  • Good general mathematical skills.
  • Good MS Office skills and ERP systems experience: SyteLine, SAP, Oracle, or similar

Equal Employment Opportunity

SaniSure LLC is an Equal Employment Opportunity Employer. We do not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by federal or state law.