* Achieve regulatory affairs compliance by providing the required documentation for RA-related filings, which includes drugs, routine annual updates, establishment license updates, and specific activities needed for international registrations or ANDA or NDA preparation. * Create eCTD/CTD documents and files to complete registrations. * Achieve regulatory affairs compliance by providing the required documentation for RA-related filings, including devices, 510(k), letters to file, device listing, and registration. * Work harmoniously with foreign countries' consultants, agents, or Ministry of Health representatives. * Represent the regulatory interests and concerns, ensuring the required information is communicated to the relevant departments to ensure regulatory compliance. * Serve as a communication conduit to collect/distribute information connected to regulatory dossiers and may participate in conducting or supporting clinical trials and scientific projects.* Monitor published scientific literature pertinent to dental anesthetic usage and experience.* Provide supporting regulatory interface for 'change control' and label copy approvals and specification/BOM changes as required.* Follow GMP and regulatory requirements and ensures quality standards are met.

* Assist supervisors in obtaining product approvals and facilitating successful market launches for Natural Health Products (NHPs), Over-the-Counter (OTC) drugs, medical devices, cosmetics, and food products.* Conduct a review of and track Good Manufacturing Practices (GMP) documentation, including Master Batch Records, Master Packaging Records, Certificates of Analysis, Annual Product Quality Reviews, Stability, etc., for products imported and marketed.* Performs all QA functions including, but not limited to: batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.* Review production and laboratory records, assisting in internal audits and self-inspections.* Support in the development of SOPs to ensure efficient and compliant Quality function.* Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.* Ensure that all medical device, drug, natural health product and cosmetic products released is of intact product integrity.* Liaise with the suppliers of medical device and/or drug and/or natural health and/or cosmetic products.* Liaise with third party Quality and Regulatory Designate.* Keep an up-to-date knowledge on company and Health Canada regulations and policies applying appropriate implementation strategies where required.* Review regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licenses, and Site Licenses/registrations.* Support all quality related exportation requirements as a QPIC (Qualified person in charge.

* Follow established protocol(s) in Specimen Processing* Ensure that all samples are properly identified, data enter, and labeled* Follow established protocol(s) for the handling of unsuitable samples* Ensure all client inquiries and problems are handled in a courteous and professional manner

* Greet customers promptly and gather prescription information according to Standard Operating Procedures.* Perform duties in priority according to Role assigned on Role Assignment Schedule.* Refer to the pharmacist all clinical inquiries, for example, those related to medication purpose, use and recommendations (including prescriptions, OTC’s, and restricted sale products); diseases and conditions; professional fees; and other inquiries as required by law or company policy.* Provide accurate information in response to customer inquiries. Resolve customer issues according to established standards, ensuring appropriate intervention by the pharmacist.* Ensure customers requiring counseling (OTC or Rx as defined by operating standards and/or legal policies) are referred to the pharmacist in a timely and appropriate manner.* Maintain and control the cash register in the dispensary in accordance with cash handling policies and procedures. * Managing customer inquiries both in person and over the phone.* Adhere to all confidentiality and privacy requirements

* Supervise research projects, identifying research goals, establishing methods and setting budgets for the facility.* Under general supervision & direction of the PI, develop and implement original experiments within the guidelines of the research.* Update and review standard operating procedures (SOP) and attain good laboratory practice (GLP) and good documentation practice (GDP).* Will assist with the experimental task to generate and purify plasmid DNA, express proteins in bacteria, maintain mammalian cells in culture, generate protein extracts, run SDS PAGE and western blotting and write up results for PI.* Conduct medical laboratory tests, experiments and analyses.* Provide PI with written detailed description of experiments and results.* Use of various biological samples (eg. Human cells in culture, sera from antibodies)

* Ensure all manufacturing process is going smoothly and efficiently. Closely monitoring employees and their organized workflows.* Support operation of the production departments to ensure that quantitative and qualitative measures included in the operating plan are met.* Promote a focus on excellence in all production activities.* Provide leadership to improve health and safety performance by preventing incidents and taking corrective actions.* Provide leadership and supervision to staff by providing work direction, performance feedback, and recommendations for training and development. * Promote a positive labour-management relationship and ensure compliance with the Company’s policy and regulations.* Ensure GMP and S.O.Ps are adhered to at all times, and that all products consistently meet specifications. * Ensure timely and thorough sanitation of all equipment and facilities to allow for efficient and on-time production start-up and delivery of products to customers.* Participate in the development and implementation of operational and capital budgets, safety compliance, training and production plans by monitoring results against plan and support corrective action plans accordingly.

* Supervise and provide guidance and direction to staff.* Responsible for hiring and managing the performance of the team. * Prepare, dispense, and control medications accurately and timely to patients.* Ensure medication and over-the-counter supplements inventory levels are adequate to meet patients’ needs.* Counsel patients regarding new and additional medications in a friendly, positive, and proactive interaction* Create awareness and educate customers through public relations.* Provide timely and favorable resolution to patient’s needs and Doctor’s requests/issues* Obtain and review budgeted sales and net contribution* Identify and report sales opportunities both internally and externally* Review and control costs at all levels within the pharmacy.

* Direct management responsibility for the production department includes blending, packing, weighing and sanitation functions. Responsible for the hiring/termination of all plant personnel and all temporary employees. Responsible for the authorization and approval for all plant overtime. Also responsible for reviewing the timecards, approving employee hours worked weekly for payroll and completing all paperwork for employee absences. Manage the plant employee performance appraisal function annually.* Ensure the highest level of quality for all manufactured products. Responsibility includes ensuring that all seasonings are manufactured according to the formula instructions and are packaged and labeled correctly. Responsible for ensuring that the ISO 9000 procedures are followed and enforced. Responsible for enforcing GMP standards in all operations of the manufacturing plant to include indirectly managing the sanitation function of the plant. Responsibility also includes strict compliance with all FDA, TX Dept. of Health, and AIB practices and procedures.* Responsible for the timely production, packaging, labeling, and delivery of quality finished products to all customers, including other IFF locations, as specified by customer service (via production orders).* Assist in the responsibility of maintaining proper raw material and finished good inventory levels to meet customer requirements and meet company turnover objectives. Key responsibility for assisting in the direction of the annual physical inventory of the division.* Ensure that all tasks are completed in a safe manner. Responsibility includes the enforcement of safety rules and procedures of the plant as specified by the local Safety and Health Manual

* Lead a team of analysts to conduct GMP laboratory testing, providing coaching, subject matter expertise, and technical mentorship* Provide troubleshooting of test method and equipment issues.* Responsible for full-cycle internal lab investigations, including trending and preventative actions.* Technical training of analysts as well as on-boarding of new employees.* Raw Material, validation/verification, and investigation sample testing.* With the Quality Control Supervisor, lead meetings to determine priorities, coordinate the workload and seek agreement with the team on group priorities.* Provide support for internal and regulatory inspections.* Recommend, design, and deliver training to ensure team technical capability and compliance with SOPs and cGMP requirements.* Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.

* Collect, organize, and correct research data in order to create representative graphs and charts highlighting results for presentations.* Develop, modify, and carry out research techniques, procedures, and tests.* Participate in seminars and symposiums to broaden knowledge and understanding.* Prepare materials for reports, presentations, and peer-reviewed journal publication submissions.* Provide students with personalized educational, behavioral, and emotional support to enable positive learning outcomes.* Help with lesson planning and curriculum implementation to expedite rollout and delivery.* Assist with classroom activities, tutoring, and reviewing work.

* Sample raw materials for QC testing and the Reference Sample program.* Perform visual inspections and dimensional analysis of incoming materials.* Record deficiencies associated with each lot received under the supplier quality history trending program.* Review all inspection records to ensure entries are correct and filled out.* Ensure all equipments used in the inspection and testing processes are calibrated.* Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.* Perform all lab functions in compliance with cGMP.* Writing and reviewing SOPs.* Perform Raw Material testing according to USP, EP, and BP.* Perform analytical testing on raw material, packaging components, utilities, and other test articles as per approved methods, specifications, procedures, and GMP.* Ability to perform techniques using UV spectrophotometry, HPLC, GC, AAS, and TOC.* Provide lab support, including reagent preparation, cleaning, and routine equipment maintenance.* Recognize and report aberrant test results and sample conditions. Report any out-of-specification (OOS), out-of-trend (OOT), or atypical results immediately to the QC Manager and participate in laboratory investigations as required* Complete all required documentation legibly and accurately. Maintain Good Documentation Practices when completing logbooks, analytical worksheets, training records, and all other GMP documents. Ensure the integrity and traceability of data generated* Collaborate with QC Supervisor and Director to optimize laboratory efficiencies, support lab coordination, and provide input to method transfer and analytical method validation studies.

* Provide advice, counsel, and guidance to patients and other pharmacists on the proper use of medications and their action in the body.* Advise patients on the safe and effective use of medications to minimize adverse reactions; counsel those who fail to adhere to prescribed drug regimens.* Assess the health status of patients, including their physical condition and mental-emotional state, to develop a course of treatment for them, utilizing scientific knowledge of drugs and their administration.* Make recommendations for treatment and follow-up therapy concerning tests or therapies the patient might need.* Advise hospital personnel on drugs for patients admitted for medical or surgical care; recommend medications for chronic diseases.* Recommend treatments for drug overdoses; work within state law guidelines; refer cases beyond the scope of practice or expertise to other agencies trained in handling such cases.* Examine new drugs on the market; test potential drug therapies to ensure they are safe and effective; inform physicians.