Job Description
Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements, and we are involved in every facet of the industry, including research, development, manufacturing, marketing, and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry level candidates that are interested in working for global company with opportunities for growth, development, competitive pay, and benefits.
Benefits: Free medical (one plan) and other medical plan options
Dental, vision, life insurance and other voluntary benefit options.
$1,000 Retention Bonus after 90 days of employment!
$1,000 Employee Referral Bonus
3 weeks vacation and 11 paid holidays
401K including company matching and profit sharing
Opportunities for advancement
Comprehensive training
Tuition Reimbursement and more!
Summary Performs microbiological testing on raw materials, in-process and finished product as well as environmental samples in a cGMP/GLP laboratory. Reports result in a timely and professional manner to QC Director/designee. Assists in OOS investigations and excursions reports.
Duties & Responsibilities - Performs routine microbiological testing on raw materials, in-process and finished products using compendial methods such as USP, AOAC, FDA-BAM and in-house validated methods on the rapid automated Soleris system.
- Performs retesting of out-of-specification (OOS) results, assists with OOS investigations and OOS reports as directed by QC Director/designee.
- Performs water sampling at various ports and performs bioburden, TOC and conductivity testing.
- Performs Environmental Monitoring testing (for air and surface) per established protocol.
- Reviews water and EM test results and assists in investigation of excursions and preparation of relevant reports as directed by QC Director/designee.
- Effectively communicates testing progress or project status to QC Director/designee.
- Documents and reports result in the appropriate notebooks, databases and LIMS.
- Performs formal review of peer notebooks and test results.
- Prepares media used for the microbiological analysis of samples.
- Performs timely cleaning and disinfection and handling biohazard and general wastes.
- Maintains supplies and media inventory for the micro lab in collaboration with the Lab Coordinators by creating needed Purchase Requisitions Forms and formally qualifying received media and reagents.
- Operates, maintains and ensures calibration of equipment including thermometers, analytical balances, pipettes and other related equipment used in the micro lab; notifies QC Supervisor of potential issues.
- Assists with new equipment qualification/ validation projects as directed by QC Director/designee Assists in developing or revising microbiological test methods.
- Trains and mentors Associate Microbiologists and Micro Technicians
- Reviews and revises Standard Operating Procedures (SOP) as directed by QC Director/designee
- Assists in implementing cGMP/GLP programs and procedures within the micro laboratory.
- Provides backup support to QC Director/designee on day to day activities or tasks, as required.
- Performs special projects as assigned by QC Director/designee.
- Complies with cGMP, cGLP, FDA and other applicable industry regulations as well as NAI policies.
Qualifications
- BA/BS degree in microbiology, chemistry, biology, biochemistry or related field with minimum 3 - 5 years' experience working in a microbiological laboratory lab, preferably in a regulated GMP industry or,
- MSc degree in microbiology, biology, chemistry, biochemistry or related field with a minimum of 1 year experience working in a microbiological lab, preferably in a regulated GMP industry
- Proficiency in aseptic technique, serial dilutions, quantitative enumeration of microorganisms, and preparation of test media.
- Experience with microbiological testing such as Bioburden and environmental monitoring
- Good computer skills with knowledge of Microsoft Word, Access and Excel. LIMS experience preferred.
- Effective oral and written business communication skills
- Ability to initiate and maintain QC data, documents, reports and corrective action summaries.
- Ability to collaborate and communicate effectively with peers and management.
- Ability to multi-task, work effectively and complete projects in a fast paced environment.
Supervisory Responsibilities *None
Physical Demands - While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear. The employee is frequently required to sit and stand.
- Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus
- Lifting requirement: ability to move 40 gallon drums for sampling water at various ports and to lift up to the maximum safety-recommended 50 pound container
The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodations may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job.
Work Environment - Computer workstation and climate-controlled office environment. Will routinely enter production areas where personal protective equipment might be required to prevent or lessens exposure to airborne-borne powdered nutritional supplement substances.
NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
Job Tags
Full time, Work at office,