QA Associate (HACCP) - North Brunswick, NJ 08902
US Pharmalab Inc (firstname.lastname@example.org)
Based in New Jersey, US Pharma Lab, Inc. is an umbrella of established custom manufacturers which specialize in the making of dietary supplements and sports nutrition products, as well as nutraceutical/pharmaceutical raw materials, catering to the needs of industry leaders worldwide. US Pharma Lab was established in 1996 and has expanded globally with manufacturing and marketing facilities in the United States, India and China.
This position is one of high regulatory responsibility that provides direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals. This position will help ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 110 and 111.
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.
E*ssential Job Functions: *
- Complete HACCP (Hazard Analysis and Critical Control Points), SQF (Safe Quality Food) and FDA paperwork in a timely and accurate manner.
- Perform a quality check of product(s); investigate product issues identified, review to identify any potential issues and communicate necessary changes in a timely manner.
- Respond to questions presented regarding product quality, food safety, and product specification or other quality related items.
- Maintain a safe work environment.
- Implements and maintains company food safety & quality assurance programs. Develops and leads implementation of plans, clearly defining the critical issues and approach to be used in resolving food safety issues. Leads all corrective and preventive actions necessary as related to the identification of food safety issues.
- Directly responsible for implementation and maintenance of the food safety plan to ensure that all prerequisite programs, preventive controls, and critical control points perform within expected standards.
- Performs all third party, customer audits and inspections. Seeks to establish constructive working relationships with inspectors and auditors.
- Responsible for reviewing results of internal facility and warehouse inspections. Implements corrective and preventive actions for on time completion.
- Responsible for monthly, quarterly and yearly reports.
- Act as the facility’s SQF Practitioner and is responsible for the maintenance and improvement of the currently implemented system.
- Responsible for the facility’s overall HACCP Compliance including the monitoring of critical control points, enforcing and revising labeling guidelines, completing and maintaining export certifications, etc.
- Basic laboratory work including environmental sampling and testing as well as raw material, in-process and finished product sampling and testing.
- Perform facility inspections and act as lead auditor for internal audits.
- Conducts activities involving quality assurance and compliance with applicable regulatory requirements.
- Assists in development and implementation of company and regulatory quality standards in the manufacturing facility.
- Maintains and ensures compliance of a qualified HACCP program
- Works to ensure the effectiveness of the Master Sanitation and Pest Control programs for the facility and any associated food grade storage areas
- Collects and Analyzes QA data from manufacturing processes to measure, access, control and improve product quality performance
- Communicates compliance results to the Quality Manager and any operating groups
- Utilizes customer and consumer complaint data to identify root cause, then communicates and provides support to implement process/product improvements
- Works with the Quality Manager to determine the disposition of all raw materials, packaging and finished product HOLD orders
- Helps maintain a Quality and Product Safety System that consistently meets regulatory, customer, and third-party audit requirements
- Function as a trained internal auditor
- Assist with training employees on food safety, food quality, company processes, and Good Manufacturing Practices
- Ability to suggest actions to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system.
- Identify and record any problems relating to Food Safety and the Quality of the ingredients, processes, quality system, or safety system.
- Helps control further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected.
- Assist with research and development for improvement of existing and new products
- Inform Management of ANY Food Safety or Quality issues or of any processes, which become non-compliant with specified requirements
- Understand and assist in maintaining compliance to FDA Regulations 21 CFR 110 and 111 for food and dietary supplements and other global food regulations as needed
- Execute the batch disposition process for raw materials, components and finished products
- Lead investigations for quality related issues through non-conformance and deviation systems, CAPA process
- Interpret and implement quality assurance standards/SOPs effectively and accurately
- Mentor the Quality Specialist performing batch record review process
- Assist and/or Lead internal audits and regulatory audits as directed by management
- Assist with equipment qualification and process validation as needed
- Provide oversight to the calibration process
- Provide oversight of the change control process
- Perform complaint investigations
- Gather, trend, and assess data and maintain metrics for Quality Assurance
- Train, support and mentor QC Inspectors that assist in providing direct production oversight
- Other projects as directed by the QA Manager.
· Meets all safety expectations and follows all safety practices.
· Works extended hours and occasional weekend overtime.
· Other duties as assigned
Education and Experience:
· Minimum of 3+ years of experience in a QA Inspector within a nutritional supplements, food, consumer products or pharmaceutical company.
· BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
- Any combination of education and experience that provides the knowledge and skills necessary to carry out the job duties; typically includes expertise in the field of agriculture and/or food safety
- Experience in a food manufacturing environment
- BS or MS in Food Science, Meat Science, Microbiology or related field and a minimum of 5 years of experience in a quality position
- Experience with SQF Food Safety Fundamentals and/or SQF Food Safety for Manufacturing
- Experience with PCR-based pathogen detection platforms
Knowledge, Skills, and Abilities:
· Demonstrates ability to work in a team and assist others.
· Able to follow written instructions precisely and perform basic math calculations as required.
· Attention to detail and accuracy with numbers.
· Understands and is knowledgeable of cGMP, OSHA standards etc.
· Must be able to distinguish different shades of colors.
· PC-based computing experience (Word, Excel)
· Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity.
· Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.
Physical Requirements (lifting, etc.):
· Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.
· Must stand and walk on production floor a minimum of 6 hours per shift
· Uses hands to finger, handle, feel, or operate objects or controls; lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.
· Occasionally works from a rolling ladder or step stool.
· Must be able wear all PPE including labcoat, face mask, booties, gloves, safety glasses.
Work Environment (Office, Warehouse, temperature extremes, etc.):
· Work is regularly performed inside a manufacturing environment where temperatures can be moderate; exposure to dust, odors, noise and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.
We offer a comprehensive benefits package. To support the health of our employees and their dependents we provide paid Vacation & Sick leave, 9.5 paid holidays, medical, dental and vision insurance plans. To support their financial well-being we offer a 401K with a generous employer match, 529 college savings plan, Flexible spending account, life insurance and short & long term disability insurances.
US Pharmalab Inc is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.
Job Type: Full-time
Job Type: Full-time
- gmp: 1 year (Preferred)
- control audit: 1 year (Preferred)
- quality assurance: 1 year (Preferred)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
This Job Is Ideal for Someone Who Is:
- Dependable -- more reliable than spontaneous
- High stress tolerance -- thrives in a high-pressure environment
- Monday to Friday
- Weekends required
- Day shift