Find & Apply For Regulatory Affairs Specialist Jobs in Gardena, California

Regulatory Affairs Specialist Custom Research Labs, Inc. - 2.7 Gardena, CA Job Details Full-time $70,000 - $80,000 a year 21 hours ago Qualifications Report preparation Communication with suppliers Confidential information handling Content creation for technical audiences Corrective action quality audits Program development Safety regulations Testing (project management phases) Technical writing experience within manufacturing Compliance audits & assessments Project management experience in manufacturing Quality control audit Manufacturing facility experience Production validation processes Attention to detail QA/QC Auditing experience within manufacturing industry Vendor communication Organizational skills Regulatory/legal compliance standards in production Conducting training sessions Quality audits Training & development Customer service problem-solving Cross-functional communication FDA regulations Pharmaceutical manufacturing facility experience Full Job Description Responsibilities & Skills Maintain and implement change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols/reports, and other GMP documents for all relevant departments. Monitor aspects of manufacturing operations which include, but not limited to: Housekeeping, Personnel and Hygienic Practices, Pest Control, Calibration and Scale Verification, Logbooks, Batch Records, Signs, and Labels. Maintain and facilitate training programs (i.e. Safety/Hazard/Hygiene/Harassment), training files, and annual audit of training files. Manage, host, and coordinate all internal and external regulatory audits/inspection with FDA or other agencies. Implement and execute monthly cGMP audit throughout the plant Manage and maintain regulatory files and control documents, MSDS, COA, Spec, Stability, etc. Develop and implement

IQ/OQ/PQ

protocols. Consult clients with artwork label and packaging review, and act as a regulatory gatekeeper and QC process for all claims, packaging, and labeling. Manage and execute OTC product registrations and listings with FDA. Manage annual renewal of permits/licenses (Local, State, and Federal). Conduct research and stay up to date with existing and emerging regulations affecting our industry at federal, state, and local levels, updating teams as needed, building relationships with external partners and third parties. Monitor evolving regulations, standards and governmental agency activities, interpret relevant information, take appropriate action to inform and educate stakeholders and revise processes as necessary. Analyze, document, and investigate customer complaints and manage to resolution and provide reports. Generate incident reports, change controls and CAPA reports, including logging, reviewing the adequacy of root cause, corrections, corrective actions, preventative actions and effectiveness till closure. Serve as a technical resource to internal and external customers or suppliers by appropriately responding to inquiries related to technical support, test parameters/methods for microbial, and analytical testing or other science-based requests. Manage existing finished goods and formula compliance and initiate change when demanded by new regulations or business practices. Provide cross-functional strategic regulatory guidance in product development to ensure chemical, formula, ingredient and packaging compliance on a domestic and international level. Participate in all phases of new product development from design, validation, and manufacturing ensuring full compliance to cGMP, OTC, FDA, EU, CANADA, standards. Prepare materials for production, samples for submission to testing laboratories, retention and stability program, and provide follow up support. Process and provide timely and accurate update of stability studies. Operate laboratory equipment and instruments, such as mixers, viscometers, pH meters, and homogenizers - leading to all the QC following GMP. Review laboratory testing and QC of incoming/outgoing raw materials, bulk product, and finished product in accordance with internal procedures and all applicable governmental regulations. Perform other related duties as assigned by management. Adhere to company policies and procedures and set a positive example for others within the organization Requirements & Qualifications Bachelor's degree in Life Science or Chemistry, or equivalent combination of education and experience preferred 5+ years regulatory/qc experience in an FDA-regulated environment in personal care/cosmetic industry required; 3+ years in cGMP manufacturing, production, formulation lab Working knowledge of FDA regulations and GMP regulations pertaining to personal care/cosmetic manufacturing, testing, validation, and documentation Experience with personal care/cosmetics, OTC, and global product regulatory support Experience with QC/QA/regulatory in the areas of auditing, training, implementation, and remediation Strong technical writing abilities and report development skills based on analytical findings Proven leadership, multi-tasking, time management, and project management skills, with ability to meet deadlines Experience developing and implementing QC/QA/regulatory compliance programs Prior experience handling, analyzing, and managing customer complaints and recalls Excellent analytical and problem-solving skills required. Must be extremely detail oriented to ensure accuracy Demonstrated experience with effective interpersonal communication with staff, customers, and suppliers. Strong ability to foster teamwork and demonstrate professionalism Proactive, self-starter with good communication and organization skills required Able to handle issues with a high degree of confidentiality Strong knowledge of computer programs (e.g. Excel, Word, MS Project, Access)

Job Type:

Full-time Pay:

$70,000.00 - $80,000.00 per year

Experience:

QA/QC:

3 years (Required)

Regulatory:

3 years (Required)

Work Location:

In person