Job Title: Laboratory Compliance Manager
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.
- Work with product team to procure ingredients needed for 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
COVID-19 considerations
AnimalBiome requires all employees to be fully vaccinated. Masks are required in all labs and some common areas of the facility.
AnimalBiome is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage candidates of all backgrounds to apply. If you are a highly motivated individual with a passion for laboratory science and a desire to make a positive impact in the world, we encourage you to apply for this exciting opportunity
Job Type: Full-time
Pay: $65,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
COVID-19 considerations:
AnimalBiome requires all employees to be fully vaccinated.
Masks are required in some areas of the facility.
We follow all state and local requirements.
Ability to commute/relocate:
- Oakland, CA 94609: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- Did you read AnimalBiome's Covid Considerations?
Education:
Experience:
- Laboratory Compliance: 5 years (Required)
Language:
Work Location: In person
