About Contraline Inc.
Contraline is a venture-backed medical device company based in Charlottesville, Virginia. The company’s lead product is ADAM™, the world’s first injectable hydrogel designed to provide long-lasting, non-hormonal, and reversible contraception for men. The company aims to use its hydrogel platform technology to address global reproductive health challenges that have no solutions and large unmet needs.
About the role
The Operations Manager will be responsible for all of Contraline’s office and lab operations. They will maintain relationships with R&D, quality, manufacturing, and facilities service providers. This role will report to the Director of Operations.
Key Responsibilities
- Lead and execute shipping and receiving processes while ensuring traceability throughout the supply chain in compliance with cGMP requirements
- Manage Purchase Requests in collaboration with Finance
- Manage and maintain the facility security system
- Be an active member on the Safety Committee and help proactively identify risks, contribute to incident prevention, and continuous improvement
- Conduct facility checks including walkthroughs and holiday schedule management
- Ensure completion of facility maintenance, cleanliness, and functionality of office and lab space while ensuring compliance with OSHA and VOSH guidelines
- Collaborate with the Director of Operations in establishing processes and documentation regarding Safety and Operations for the facility
- Manage biohazardous and chemical waste disposal programs
- Manage office and break room inventories
- Collaborate with the individual(s) responsible for Equipment & Inventory Management
- Develop and communicate reports for areas of responsibility
- Contribute to the overall company culture by planning events
- Assist the Director of Operations with other projects and functions, as needed
- Collaborate with internal and external partners on component qualification
- Maintain Design History and Risk Management Files along with related records for Contraline products (DHF/RMF, DMR, DHR, etc.)
- Provide Quality Engineer and Design Assurance support to Engineering and Operations to ensure risk-based approaches and compliance with applicable regulations
- Drive and support updates to Quality System documentation as needed
- Assist in supplier sourcing and performance management activities
- Support internal, external and supplier audits as needed
- Manage supplier communication and assess for appropriate change management activities
Experience and Qualifications
Qualifications:
- B.A. or B.S. degree and minimum of 3-5 years of relevant professional experience
- Experience working in the biotech/pharmaceutical/medical device industries or other lab settings is highly preferred
- Experience with ISO9001, ISO13485, FDA 21CFR820, or other GMP regulated industries are preferred, but not required
- Exceptional multi-tasker with ability to perform in a fast-paced environment while maintaining vigilant attention to detail
- Ability to work independently and be the ultimate problem solver
- Being proactive and having desire to take initiatives
- Excellent organizational skills
Sector
Devices & Instrumentation
Job Type
Full-time
Benefits
- Health
- Dental
- 401k
Address
Charlottesville, VA
Upload your resume to apply for this role through CvilleBioHub. If the company accepts applications through email, they will also receive your resume.