Biotech QA Documentation Specialist

Join Our Journey:

Joining Movora is more than just a career choice; it's an opportunity to be part of a pioneering team that's leading the way in veterinary health. Every connection we establish and each impact we create contributes to the greater goal. At Movora, your role goes beyond just a job title; you become an integral part of a movement that truly makes a difference – benefiting you, our team, the wider community, and pets across the globe.

At Movora, our Employee Value Proposition is deeply rooted in our Core Values and Vision. It reflects our commitment to enhancing the lives and mobility of companion animals, embodying who we are and what we strive to achieve.

Empowering You: Your growth is our priority. We're here to nurture your talents and cheer on your success. You bring the skills; we provide the support and opportunities.

Teamwork & Integrity: With a spirit of collaboration, we respect and trust each other. Your contributions help us advance veterinary health as one strong, skilled team.

Inclusive & Fair: Movora is your home away from home. We're dedicated to diversity, work-life balance, and ensuring everyone gets their fair share of rewards and recognition.

Salary: $55,000-75,000 DOE

Position Summary:

The Biotech QA Documentation Specialist for our veterinary tissue banking operation supports the implementation and maintenance of established quality management systems (QMS), with a focus on ensuring that production processes and final products adhere to established standards for our veterinary Allograft solutions. This role involves meticulous documentation management, equipment monitoring, and participation in audits, playing a key part in maintaining consistent product quality and compliance. Veterinary Tissue Banking enables the manufacturing of donor bone graft used in many veterinary orthopedic surgeries and veterinary dental applications.

Essential Duties and Responsibilities:

* Please note that experience in software development or related fields is not relevant to this position and will not be considered in the evaluation process.

Quality Assurance Program Development

• Donor & Batch Record Management: Oversee the creation, organization, and review of donor charts and processing batch files to ensure completeness and compliance. Manage Quarantine Release documents.

Quality Control Activities:

• Support Tissue Processing: Assist in tissue procurement and processing activities, ensuring readiness and compliance.
• Validation & Qualification: Design and conduct validation studies and equipment qualifications. Maintain thorough equipment recordkeeping and manage calibrations.

Quality Control & Assurance Activities:

• Documentation Management: Assist in the creation, review, and organization of production and quality records, including donor and batch records, to ensure accuracy and compliance with SOPs.
• Labeling Control: Support the development and management of labeling for products, ensuring labels meet regulatory and quality requirements.
• Process Monitoring: Monitor production processes to ensure adherence to quality standards and identify opportunities for improvement.
• Audit Participation: Assist in conducting internal audits of production processes, equipment, and systems to verify compliance with quality management systems.
• Incident Reporting: Participate in the investigation and documentation of incidents, errors, complaints, and adverse reactions, and help implement corrective actions as necessary.

Environmental & Quality Maintenance:

• Environmental Monitoring: Help maintain the environmental monitoring program, ensuring that the production environment meets regulatory and quality standards.
• Process Improvement: Contribute to identifying areas for process improvements and assist in implementing corrective and preventive actions.

Documentation & Records Management:

• Document Control: Assist in maintaining current and archived versions of Standard Operating Procedures (SOPs), job aids, forms, and other quality-related documents.
• Training Documentation: Help manage training records to ensure that all staff are adequately trained and that training documentation is up-to-date.
• Quality Reporting: Assist in preparing quality documentation and reports by collecting and analyzing data from production and quality activities.

Additional Responsibilities:

• General Support: Provide support in answering client questions and performing other tasks as needed to ensure the smooth operation of the quality assurance program.

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to the job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.

Knowledge/Skills/Abilities:

Quality Management Systems (QMS): In-depth understanding of QMS principles, including ISO standards, GMP, and other regulatory frameworks relevant to tissue banking and medical manufacturing.

Regulatory Compliance: Familiarity with FDA regulations, AATB standards, and other guidelines critical for ensuring compliance in tissue banking and medical devices.

Analytical Thinking: Strong ability to analyze complex data, identify trends, and make informed decisions to ensure quality and compliance.

Attention to Detail: High level of precision and accuracy in reviewing documents, performing audits, and handling quality control tasks.

Problem-Solving: Proficiency in identifying problems, generating effective solutions, and implementing corrective actions promptly.

Organization & Time Management: able to work independently with minimal supervision, planning, scheduling, and organizing professional schedule to complete actions within established deadlines, handling multiple priorities with strong attention to detail.

Education: BS in Biology or related field; equivalent experience will be considered.

Experience:

• Minimum of 2 years in QA/QC programs, and 3 years in tissue banking, medical manufacturing, laboratory procedures, or sterile/clean room environments. Required experience. Please note that experience in software development or related fields is not relevant to this position and will not be considered in the evaluation process.
• Strong communication, documentation, and organizational skills with a high attention to detail.
• Proficiency in MS Office (Word, Excel, PowerPoint, Access).
• Familiarity with Universal Precautions and experience handling potentially contaminated tissues is preferred.
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Strong focus on customer needs and the ability to translate customer feedback into quality improvements.

About Movora

Movora is the place for leaders with the ambition to shape the future in our field of veterinary MedTech.

With decades of expertise in the advancement of animal health, we have the vision, drive and passion to lead and transform veterinary MedTech for many years to come. Together, our team focuses on pet health and mobility as a single resource for industry-leading medical technology - from classroom to clinic, sharing the goal of extending and enhancing pets' lives.

Benefits Offered:

• Health & Wellness: A well-rounded benefits program featuring medical, dental, vision, life insurance, short and long-term disability options, and an Employee Assistance Program.
• Retirement Planning: Participate in our 401(k) plan, with Movora matching 100% of your first 4% contribution. Please see plan summary for more details.
• Work-Life Balance: Earn paid time off (PTO) according to our guidelines, starting with the equivalent of 10 days each year for your first 3 years, you may carry over up to 40 hours each year. We also have programs such as Summer Hours from June to August.
• Holiday & Personal/Sick Time: You will also be provided with 40 hours of Sick/Personal time to be used for illness, doctors' appointments, school meetings for your kids, etc. Movora offers six company-paid holidays and one floating holiday annually.
• Additional Voluntary Benefits: Choose from optional programs such as Accident Insurance, Critical Illness and Volunteer Programs.

As a drug-free workplace, we conduct mandatory drug screens for all prospective employees. Please be advised that a drug screen will be administered as part of the pre-employment process. This screening is a standard procedure designed to ensure the well-being and safety of all team members.

Movora is an equal opportunity employer. We are committed to providing an inclusive and diverse workplace where all employees are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We actively encourage candidates from all backgrounds to apply for our positions. We believe that a diverse workforce enhances the quality and innovation of our work.

Join us in fostering an environment that promotes equal opportunities and celebrates diversity.

If you need assistance and/or a reasonable accommodation in the application or recruiting process, please contact hr@movora.com

Compensation details: 55000-80000 Yearly Salary

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