Universal Balancing (now part of Burke Porter, an Ascential Technologies Company)

Manager, Document Control

SAN DIEGO, CAPosted 30+ days ago

Job summary

  • Job post source

    This job is directly from Ascential Medical and Life Sciences, part of Burke Porter.

  • Job overview

    The Manager, Document Control leads the document control function and manages electronic Quality Management Systems to ensure compliance with regulatory standards in the life sciences industry.

  • Responsibilities and impact

    The role involves managing document lifecycles, leading a document control team, administering eQMS and related SaaS systems, ensuring software validation compliance, supporting audits, and providing training on document control procedures.

  • Compensation and benefits

    The position offers an annual salary range of $127,000 to $164,000 based on experience, along with a comprehensive benefits package including health insurance and retirement plans.

  • Experience and skills

    Candidates require a bachelor's degree (MS preferred), 7-10 years of document control experience in life sciences, 5 years in management, hands-on SaaS system implementation experience, and expertise in FDA and ISO regulatory compliance.

  • Work environment and culture

    The company values strong internal and external partnerships, adherence to policies and core values, and provides a moderately noisy on-site work environment in San Diego with limited travel.

  • Company information

    Ascential Medical and Life Sciences specializes in precision engineering and automation for medical devices and diagnostics, operating under Burke Porter, an Ascential Technologies Company.

  • Job location and travel

    This is an on-site position located in San Diego, California, with limited travel requirements.

  • Unique job features

    The job uniquely involves managing SaaS-based eQMS and related systems, leading software validation under FDA 21 CFR Part 11, and overseeing complex data migration projects in a regulated environment.

Company overview

Universal Balancing, now part of Burke Porter Group under Ascential Technologies, specializes in advanced balancing solutions for industries such as automotive, aerospace, and manufacturing. The company designs and manufactures precision balancing machines and systems, enabling clients to enhance operational efficiency and product quality. With a history rooted in innovation, it became a trusted name in global markets before its acquisition by Burke Porter, a leader in intelligent testing and assembly solutions. This integration reflects a strategic focus on expanding technological capabilities and global reach.

How to land this job

  • Tailor your resume to highlight leadership in document control management, emphasizing experience with eQMS, SaaS system administration, and compliance with FDA 21 CFR Part 11 and ISO standards relevant to life sciences.

  • Showcase your expertise in software validation, including developing validation protocols and managing the validation lifecycle for electronic systems in regulated environments.

  • Apply through multiple channels such as Universal Balancing's corporate website, Burke Porter's career page, and LinkedIn to maximize your application visibility.

  • Connect with current employees in the document control or quality management teams at Universal Balancing or Burke Porter on LinkedIn, using ice breakers like commenting on recent company projects in medical device innovation or asking about their experience with eQMS implementations.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'document control leadership,' 'eQMS administration,' '21 CFR Part 11 compliance,' 'software validation,' and 'SaaS system management' to ensure it passes initial screenings.

  • Leverage Jennie Johnson's Power Apply feature to automate tailored applications, find multiple application portals, and identify LinkedIn contacts for networking, allowing you to focus your time on preparing for interviews and skill development.

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