Open positions
Job Summary:
We are seeking a highly skilled and experienced Laboratory Compliance Manager to oversee the compliance activities in our production laboratory. The successful candidate will be responsible for ensuring that all laboratory activities are carried out in compliance with applicable regulations, standards, and guidelines. They will work closely with laboratory staff to develop and implement compliance policies, procedures, and processes. The Laboratory Compliance Manager is also responsible for ensuring the quality control of all finished goods. The role requires a strong understanding of quality control procedures and contract manufacturing processes.
Key Responsibilities:
Lab Compliance
- Develop and implement compliance policies, procedures, and processes that meet regulatory requirements and industry best practices
- Ensure laboratory staff comply with regulations, standards, and guidelines, and that laboratory operations meet quality and safety standards
- Establish and maintain appropriate documentation, including SOPs, training records, and compliance reports
- Develop and implement a training program for laboratory staff on regulatory compliance and quality assurance
- Manage and conduct internal audits to ensure compliance with regulations and standards
- Develop and manage a corrective action and preventive action (CAPA) program to address non-compliance issues and ensure continuous improvement
- Provide guidance and support to laboratory staff on compliance-related matters
- Monitor regulatory developments and changes to ensure laboratory compliance with new or updated regulations
- Liaise with regulatory agencies and auditors as required
- Ensure that laboratory operations are conducted in an ethical and responsible manner
Laboratory Production Quality Control
- Monitor and oversee the logs of testing on stool bank material to ensure compliance with regulatory requirements and company standards
- Monitor and oversee the logs of routine maintenance on all lab equipment to ensure they are functioning correctly and in compliance with regulatory requirements and company standards
- Conduct viability testing on powdered products to ensure they meet established specifications and are free from contaminants
- Oversee and conduct routine testing of raw materials to ensure they meet quality control standards
- Independently verify the quality of finished goods to ensure they meet regulatory requirements and company standards
- Manage the documentation and records related to quality control processes and ensure they are up to date and accurate
- Update and maintain QC and testing protocols for all products
- Collaborate with cross-functional teams, including production, supply chain, and regulatory affairs, to ensure quality control processes are effectively integrated into our operations
- Identify and implement improvements to the processes
Raw materials and Contract Manufacturers
- Develop and maintain strong relationships with contract manufacturers to ensure timely and accurate production of finished goods
- Coordinate with contract manufacturers to provide finished products that meet our specifications and quality requirements
- Coordinate with external vendors and partners to ensure timely delivery of laboratory supplies, services, and finished products
- Source raw materials for production, negotiating pricing and contracts with suppliers
- Conduct viability tests on products received to ensure they meet established specifications and are free from contaminants
Industry Monitoring
- Continuously monitor industry trends and regulatory changes to ensure our quality control processes remain up to date and compliant
- Maintain an up-to-date understanding of the latest developments in laboratory science, equipment, and technology
- Look for opportunities to improve quality and efficiency in the production laboratory
Qualifications:
- Bachelor’s degree in Animal Science, MS Preferred
- At least 5 years of experience in a laboratory compliance role, preferably in a production environment
- In-depth knowledge of applicable regulations, standards, and guidelines, such as GLP, GMP, ISO, and FDA regulations
- Strong leadership, communication, and problem-solving skills
- Proven track record of developing and implementing compliance policies, procedures, and processes
- Experience in managing and conducting internal audits and implementing CAPA programs
- Strong attention to detail and organizational skills
- Strong knowledge of laboratory operations, quality control, and regulatory requirements
- Strong analytical and problem-solving skills
- Excellent communication and collaboration skills
- Strong understanding of quality control processes
Salary Range: $65,000 – $80,000
Interested candidates should send a resume and cover letter to: mj@animalbiome.com
AnimalBiome, a leading biotech company that uses cutting-edge microbiome technology to analyze and restore the gut health of cats and dogs, is seeking a Laboratory Technician to join our growing team. The Laboratory Technician will report to the Production Laboratory Manager and will be responsible for contributing to the running of a stool bank, preparing materials for diagnostic testing and veterinary clinics, and making capsules and other products from various raw materials.
Responsibilities:
- Contribute to the running of a stool bank of material from healthy cats and dogs
- Process donations of fecal material, removing unwanted portions and preparing it for storage
- Prepare material for diagnostic testing for parasites and pathogens
- Prepare raw materials for use in veterinary clinics as well as for consumers
- Make capsules and other products from various raw materials
- Maintain and clean laboratory equipment
- Work with equipment to weigh, measure, process, and bottle new therapeutics made in our laboratory
- Clean and maintain production equipment for everyday use
- Bottle and prep materials for DTC and wholesale customers
- Count inventory and assist in placing orders
- Intake raw materials and prep them for storage
- Repackage products for sale on multiple platforms
- Log tasks and quality assurances on multiple platforms
- Assist in other duties that support the Supplement Production Lab
Working Conditions:
- The employee must perform tasks that require the use of personal protective equipment, such as safety glasses, protective laboratory clothing, masks, and gloves
- Laboratory environment may smell of fecal matter, fish oil, kelp, pumpkin, etc.
- Requires work in an environment where animal feces are processed
- May require extended or alternate work hours based on production requirements and business needs
Knowledge, Skills, and Abilities:
- General computer skills and ability to learn and master databases and data recording
- Familiarity with Google Suite
- Ability to maintain detailed records of lab procedures
- Ability to work under deadlines with general guidance, excellent attention to detail, and the ability and willingness to learn new methods and implement them
- Prior academic/professional knowledge in animal science, health, or behavior
- Current or recent experience with companion animals (including personal pet ownership)
- Ability to work well with colleagues and be a team player
Education & Experience:
- Associate’s degree in Animal Science or related field (Bachelor’s preferred)
- Minimum of two years working in a veterinary clinic as a veterinary technician
Salary Range: $50,000 – $60,000
This is a full-time position located in Oakland, California.
AnimalBiome is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage candidates of all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other legally protected status. All applicants must be able to show proof of eligibility to work in the United States.
All employees must be fully vaccinated against Covid-19 with a booster in the last 12 months
To apply, interested candidates should email a resume with a one-page cover letter to becky@animalbiome.com. The position will remain open on a rolling basis until filled.
Don’t see a position that fits you?
Send us an email with your resume to team@animalbiome.com.
