Job Description
Global Chemicals Corporation is an industry leader in sourcing, processing, manufacturing, packaging and wholesale distribution of high-quality food and pharmaceutical ingredients and custom manufacturing services; Our Company specializes natural and synthetic ingredients for Food and Beverage, Cosmetic and Personal Care, Nutritional and Pharmaceutical, Commercial and Industrial Applications. Our Company also is developing Active Pharmaceutical Ingredients (APIs), Excipients including carriers, fillers, additives, preservatives and colorants to pharmaceutical manufacturers and compounding pharmacies servings human and animal health sectors of the pharmaceutical industry in the United States and the rest of the world. To meet its growth requirements of growth, the Company is now seeking experienced account executives and talented and quick-learning self-starters to enter the food and pharmaceutical industries. The position currently opened is Director of Quality Assurance and Regulatory Compliance with following described responsibilities. The job holders will work at our facility located in East Brunswick, New Jersey. Office hours are 8:00 a.m. to 5:00 p.m., Monday through Friday with 1-hour lunch time.
Job Location:
Piscataway, NJ
Job Type:
Full Time
* Market Level Salary Plus Performance Bonus for Experienced and Chemistry or Food Science Degree Holder (Bachelor’s in Organic Chemistry is Required)
General Description:
The Overall Duties and Responsibilities of our Company’s Analytical Chemist and Compliance Associate involve sampling, testing and analyzing chemicals and natural ingredients using U.S. Pharmacopeia (USP), National Formulary (NF), Food Chemicals Codex (FCC) and other methods approved by our Company for distribution, production and packaging and regulatory compliance with FDA, USDA, and state and local government agencies. Be the hands-on person and team lead to assist the Company’s Director of Quality Assurance and Regulatory Affairs and Senior Management of a fast growing privately held business in training, guiding, leading and motivating the company’s team members with respect to productivity, workplace safety, regulatory compliance, quality assurance and production/fulfillment of customers’ orders with maximum accuracy and efficiency. In this role he/she will assist the supervisor in managing the activities of production planning, engineering, production, safety, production engineering & factory flow, quality assurance, material control/inventory management, maintenance, safety and compliance. This job holder will be expected to help our company’s senior management formulate production, demand planning and sales and marketing strategies and track ongoing performance against the key performance indicators (KPIs), propose and recommend continuous improvements to the senior management and implement Lean Manufacturing/Distribution policies and practices and Six Sigma principles.
For successful performance of the duties and responsibilities described above and hereunder, the job holder will be provided with adequate training by FDA-accredited third-party certification bodies and will obtain certificates of completion in individual names for such training for successful performance of the duties and responsibilities required of this position and the costs and expenses for such training and certifications will be fully paid for by our company.
Duties and Responsibilities
Analytical Chemistry:
Conduct analysis and perform evaluation and optimization of methodology with regard to samples for assay, impurities, dissolution, content uniformity, moisture, and other physical and chemical tests as necessary, in a timely manner, following appropriate analytical procedures.
Follow good documentation practice and document analytical tests on lab notebooks timely and accurately.
Follow and comply with existing SOPs and recommend improvements and updates with respect to our company’s policies and procedures on quality and safety assurance.
Review and ascertain analytical data to ensure reliable and accurate analytical data generated by lab analysts.
Perform analytical test procedures and prepare draft analytical reports for supervisor to review;
Provide recommendations to lab supervisor / manager to improve analytical procedures, SOPs, and/or lab efficiency.
Assist Supervisor in planning and prioritizing analytical tests accordingly so that the project timelines are met.
Participate in and perform assigned tasks for R & D projects in custom formulation, process development, pilot scale production technologies.
Perform other duties as assigned by our company’s management.
Regulatory Compliance:
Assist in implementing our Company’s Quality Assurance policies, procedures and practices and ensure compliance with our Standard Operating Procedures (SOPs), BRC/FSSC22000/SQF, US FDA’s FSMA-mandated Preventive Controls for Human and Animal Food, HACCP (HARPC) and cGMPs for Food and Pharmaceutical Industries, FSVP and Food Defense Plans, Kosher and Halal standards, Responsible Care /Responsible Distribution and Product Safety and Work Environment Safety programs at our distribution and custom processing facilities; deal with all relevant parties including quality, safety and health authorities, ensure compliance with all applicable regulations (customs, transportation, labor, environmental, health departments including USDA, FDA, DOT, EPA and OHSA and their state and local level counterparts).
Assist in developing, update and implementing our Company’s Standard Operating Procedures (SOPs) to comply with BRC, FSSC22000 and other quality/regulatory systems and standards required by the Company; Monitor compliance of the Company’s operations, conduct internal audits and prepare and implement Corrective and Preventive Action (CAPA) reports for non-conformances identified by internal and external auditors; Conduct outside audits of suppliers’ facilities and manufacturing plants when required in accordance with applicable regulatory compliance requirements mentioned above; Negotiate, schedule, and arrange audits of our Company’s facilities and training of our Company personnel through third party auditors and trainers such as SGS and NSF International accredited by the US FDA.
Assist in implementing our Company’s EHS (Environmental, Health, and Safety) compliance requirements; Lead and Manage our EHS Team, Be responsible for the availability and accurate maintenance of our Company’s EHS records, and developing manuals for compliance programs (including but not limited to): OSHA, DOT, EPA, NJ EPA, FDA, DHS, Local Emergency Planning & Coordination, Local Fire Department, Municipal/Township Ordinances; Design and implement measures to assure continuous “audit ready” state of compliance at Company’s facilities with governmental environmental, health and safety (EHS) standards; Develop training materials, policies, and procedures for maintaining workplace safety in the areas including but not limited to: warehouse and production room safety including but not limited OHSA compliance, workers protection, loading dock safety, forklift safety, fire safety, electrical safety, chemical safety, etc.; Develop and implement programs and policies for monitoring, controlling, and preventing chemical, physical, and biological hazards at the facility.
Other tasks and matters assigned by the Company’s Senior Management from time to time.
Sourcing:
Building vendor relationships with sources of pharmaceutical excipients, active ingredients, and other pharmaceutical products
Obtaining, gathering and organizing as much as possible product data, specifications, manuals, photographs, videos and other information of merchandise offered to us, and if needed, travel to meet with suppliers and manufacturers.
When applicable, arranging sampling/testing of potential materials for purchase by in house lab or qualified third party testing inspection & companies.
Providing assistance in purchasing merchandise from vendors, negotiating pricing, delivery and payment terms in the best interest of our company as a customer, monitoring vendors’ performance, exercising problem solving skills;
Identifying and providing necessary background information with respect to new vendors and once the new vendors have been approved, performing the duties same as above
Expediting open orders, monitoring inventory and coordinating with our warehouse personnel, account executives and customer service representatives.
Coordinating with quality control personnel in regards to reporting and dealing with quality issues and packaging problems such as non-compliance with our quality and packaging standards, requesting and arranging return and replacement, withholding payment and seeking credit and compensation from vendors, demanding vendors to take corrective action, filing insurance claims if it is applicable and coordinating with insurance surveyors and claims adjusters, coordinating and cooperating with government regulatory agencies at the direction and under the guidance of the Company’s management;
Handling all other matters related to the supply chain issues as designated by the Company’s management from time to time.
Qualifications/Requirements:
Bachelor’s Degree in Chemistry, Food Science, Pharmaceutical Science is required; however, Master’s degree in chemistry, food science, pharmaceutical science is a strong plus; Candidates with GPA 3.75+/4.0 and experience in wet/bench chemistry and pharmaceutical testing or organic chemistry, biochemistry or food science laboratory research experience in an academic setting or food chemicals and pharmaceuticals manufacturing and research and development settings.
Hands-on abilities with variety of analytical instruments, such as HPLC, GC, Dissolution tester, UV/Vis spectrophotometer, FTIR, Karl Fischer titrator, Particle Size Analyzer using US standard sieve pans and laser diffraction, etc.
Strong motivation and desire to succeed in career development and willingness to commit and devote to hardworking ethics for financial success as an individual and for the benefit of the Company are essential for this position. Having excellent leadership skills and demonstrating strong ability to motivate and lead team members are very much preferred.
Language ability – A high degree of proficiency in English is absolutely required. Emphasis is given to fluency in English speaking and the ability in writing error-free business and professional emails, letters, faxes, memos, reports and proposals in English.
3 to 5 years of Analytical Bench Chemistry experience and quality control/quality assurance and regulatory affairs in the Food, Dietary Supplement and Pharmaceutical Industries and technical education and knowledge in chemicals, food ingredients, pharmaceutical actives and excipients or industrial and mechanical products.
Strong interpersonal and communication skills and proven negotiating and problem-solving skills
Willingness to travel for up to 5% to 10% of the time on annual basis; willingness to work after normal business hours or on holidays when the need arises in the best interest of the company and our customers.
Willingness to be trained in other functions or departments and willingness to help out or cover the duties and responsibilities of other co-workers whose occasional absences have been permitted by the management or as designated by the management to help out in situations where there is a temporary surge of work in other functions.
Personal Qualities:
Integrity & Trust
Excellent Work Ethics
Positive Attitude and Progressive Thinking
Ability to Learn Quickly
Action and Performance Driven
Business Acumen
Pursuit of Continuing Professional Education
Ability to Deal with Ambiguity
Ability to Exercise Common Sense and Sound Judgment
Ability to Work Independently or as a Team Member or Group Leader
Negotiating and Adjusting to Reach Targets and Goals
Drive for Success and Pursuit of Excellence
Time Management, Pursuit of Efficiency and Productivity
Prioritizing and Multi-Tasking