Derick Ani

• Manage, leads oversees all QMS functions under the regulatory cGMP guidelines of the FDA, MDSAP, EPA - OTC, Medical devices and cosmetic grade finished product
• Hosts company-wide quality/regulatory scheduled quality case report updates to include NCRs, CAPAs, Complaints, SCARs, Deviations, OOSs, Change Controls with management team and board members
• Direct quality assurance teams, shortened validation turnaround times and reduced customer complaints.
• Developed and maintained records of policies, procedures and best practices to support continuous improvement for the chemical industry.
• Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
• Specified quality requirements of raw materials with suppliers.
• Reported production malfunctions to managers and production supervisors.
• Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
• Inspected products and worker progress throughout production.
• Applied coaching techniques and tools to support managers and team members in improving performance.
• Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
• Leads a team professional quality associates and provides guidance to staff on interpretation and implementation on polices
• Strengthen supplier quality management through supplier audits, questionnaires, quality agreements, establishing specifications, etc.
• Audit internal departments and reported findings to department heads for quality improvements.
• Performs strategic risk assessments to determine areas of highest risks and needs for potential controls
• Oversees quality functions ensuring that the receipt, warehousing, assembly and distribution of products to conform based on BSI's governed standard operating procedures to comply with regulatory standards.
• Establish and oversee company-wide Quality Management System (QMS), maintaining compliance with cGMP guidelines with respect to MDSAP/FDA/EPA regulatory standards and enhancing internal outcomes.

Responsible for all aspects of the quality compliance for ophthalmic medical devices including:

• The Quality management system and documentation including: CAPAS, Change Controls, Facility and Equipment Qualification, Process Validation, Procedures, Document Control monitoring, Customer Complaints, Management of non-conforming materials from receiving to in-house products to supplier non-conformances
• Maintenance and improvement of QMS in accordance with ISO 13485:2016 in medical devices.
• Internal audit program design and implementation in accordance with ISO 13485:2016
• Compliance training for Quality members, Production Management and Quality/Regulatory onboarding for all incoming employees including production operators
• Improved quality processes for increased efficiency and effectiveness.
• Updated quality control standards, methods, and procedures to meet compliance requirements.
• Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
• Developed and deployed production control plans, including creating all related work instructions and procedures.
• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
• Evaluated quality problems and performed assessments to identify and resolve issues.

• Responsible for directing activities that support and monitor quality essentials for portfolio of over 1000 products by overseeing daily operations in Quality Control and laboratory operations
• Responsible for creation of effective Quality Systems within the company: Material Review Systems and lead the Material Review Board, Out of Specifications System, Corrective and Preventative Action [CAPA], Customer Complaints System and the Deviation Justification System; creating and executing HACCP Plan
• Ensures compliance to company policies, set up Quality Systems within the company and ensure that the team abides by the set standards set, as well as other regulatory and quality organizations and standards, and cGLP best practices, cGMP, under the Code of Federal Regulations TITLE 21 Parts 111, 117, 700 & 701
• Ensures compliance with all applicable regulations, standards, systems, procedures and practices, ranging from FDA, Organic, Kosher, Whole Foods through the Indiana State Health Department certifications
• Co-plan and Co-execute with CEO and COO, Inventory Control, Operations Manager, Controller, Sourcing and other leadership roles to ensure on-going compliance and product quality
• Reviews and audits departmental documents for appropriate distribution and filing
• Drafts and approves standards, specifications and procedures for processes, facilities, products and tests
• Determines the identity and content in material within inventory portfolio and biomass from original material to ensure product integrity
• Maintains compliance with FDA and other certifying bodies
• Leads the Department of Health's proficiency studies
• Collaborates with business units for cost model analysis
• Established analytical test methods and assurance for data integrity
• Developed products and technologies that met product performance, quality and timing requirements
• Analyzes and monitors team analytical chemists' organic compounds to determine their chemical properties
• Conducts quality control tests and directed test procedures
• Drafts standards and specifications for processes, facilities, products and tests
• Organizes due diligence in preparation for setting up Quality Systems and directing all members of the company to follow Quality procedures through training and maintaining to following up when the procedures are deviated
• Initiated a program that standardized product refinement system by setting up procedures and work flows to increase interdepartmental information for the financial, inventory control, laboratory to quality and supply chain management
• Builds strategic alliances with the quality teams of clients that resulted in confidence within company's not only quality standards but also boosted revenue
• Responsible for narrating, authorizing and approving: standard operating procedures, raw specifications, forms, master manufacturing records, safety data sheets, manufacturing work flows, certificate of analyses
• Issuing statements on behalf of company's quality department for: Natural Certification, FSMA, Allergens, IFRA, NON-GMO, Pesticides, Origin, Kosher and Organic Certification
• In the process of Organic certifying the facility and the product inventory
• Routine audits for interdepartmental batch records, labeling and other record keeping to ensure everything meets quality standards
• Manages retained sample handling, receiving, storage and inventory
• Develops, maintained and improved experimental data spreadsheets
• Certified through NSF's Vendor Qualification and Auditing
• Certified through NSF's 21 CFR 111 Dietary Supplement Group
• Set up control processes in manufacturing operations for preliminary, in progress, hidden damage and final product inspections
• Identifies and helps resolve non-conforming product issues
• Collects samples during production and tested randomly to determine in-process product quality for audit purposes
• Inspects outbound shipments and conducted random sampling to ensure product quality for audit purposes and daily operations
• Performed frequent visual inspections to root out tolerance and compliance issues
• Rejects defective products and approved correct products
• Implemented quality control processes with critical control points throughout company
• Collaborates with CEO and COO to develop scopes and implement project plans
• Trains, coaches and mentors staff to ensure smooth adoption of newly merged quality program
• Maintains work peers' allegiance and trust by being involved and always available and having a "hands-on" management style
• Created and deployed best practices to improve efficiency and reduce defects.

• Analyzed organic and inorganic compounds to determine their chemical properties
• Maintained laboratory instruments and developed new laboratory equipment
• Conducted quality control tests and directed test procedures
• Routinely calibrated scales to minimize leakage due to calibration errors
• Determined equipment operating efficiency
• Interpreted test results and developed nonstandard tests
• Drafted standards and specifications for processes, facilities, products and tests
• Ordered chemicals for analysis and prepared reagents for analysis
• Maintained compliance with DEC and EPA
• Set up standards for sampling analysis and data interpretation using effluent analysis
• Developed products and technologies that met product performance, quality and timing requirements
• Maintained records and quality documents for drinking water and A2LA audits