What are the responsibilities and job description for the Incoming Raw Materials, Quality Control Technician position at Adept Life Sciences?
About the Company:
Adept Life Sciences is a leading manufacturer of specialty supplements and private label for leading national and global nutritional marketers and retailers. Our high-quality standards and superior innovation have attracted many leading supplement brands and driven rapid growth. Our state-of-the-art, environmentally friendly facility in Gilbert, Arizona, exceeds cGMP standards and is one of the finest in the country. We are a family owned and operated company with a focus on creating a great company culture for our team members.
Position Summary:
This position is responsible for sampling, testing (both internal and 3rd party laboratories), reviewing, releasing or rejecting all incoming raw materials, in-process production and finished products to ensure specifications are met against specifications. By working closely with 3rd party laboratories, you will maintain the relationship and work diligently with the labs to meet timelines and guaranteed lead times to ensure planning, production and operations run efficiently. This position will maintain all sampling and retain logs as well as collection, checking and filing sanitation, maintenance and production logbooks to ensure the company is following internal SOPs, GMP practices and compliance with Title 21 CFR Part 111.
Job duties including but not limited to:
- Sample all incoming raw materials and finished product for retention and analytical testing to verify specifications are met, following written company SOPs (21 CFR 111.75).
- Perform inspection of ingredients, capsules, packaging and labels to ensure specifications are met (label control, 21 CFR 111.155.)
- Perform organoleptic inspection of all incoming raw materials.
- Sample and perform Identification (if applicable) and Microbiological testing for raw materials and finished product.
- Manage in-house movement for Identification of raw materials once first lot is sent out for testing and we have a standard to test in-house. Update testing sheet to move to internal testing.
- Fill out Chain of Custody forms for samples sent to 3rd party laboratories (raw materials, finished product and in-process samples).
- Maintain sampling and testing log to include all samples pulled and/or given by production by material/FP, size of sample, number of sample(s), date sample shipped or logged into retain, lab used if applicable and estimated test result date. Any late or OOS materials or finished product should be noted on sheet and separate report written for monthly lab scorecard. Keep files of receipt of testing results from 3rd party analytical labs.
- Management of all 3rd party analytical labs to include lead times, tracking on-time delivery, customer service and pricing. Maintaining lab scorecard to be shared with upper management monthly.
- Communicate with labs daily to keep up to date on testing results, logging updates daily and keeping in communication with planning and production to keep operations running and allowing planning to schedule production.
- Investigate any OOS and follow SOPs with procedures. Report any lab OOS to Quality Assurance, Document Control Specialist and Quality Manager. Share any delays due to OOS in daily production meeting.
- Work with Quality Document Control Specialist, Quality Manager and Procurement with any OOS raw material for rejection of material.
- Responsible to update Netsuite on all testing with dates testing is due to release. Any changes to the original date should be logged separately and clearly communicated during OP meetings daily.
- Manage Quarantine and release of incoming, in-process and finished product pending testing results and/or batch review. Responsible for labeling product on hold or released. Responsible for movement of materials into Quarantine if rejected or OOS with internal communication verbally and written.
- Same day release of passing RM and/or finished product.
- Write Certificate of Analysis for finished product and turn in with Document Control Specialist for check and signature. Maintain 24hr turnaround from test result to signed and released raw material and/or finished product.
- Responsible to log and place in retain bins: incoming raw materials, in process samples and finished product samples.
- Maintain and update at risk material list and new materials, finished products to log testing requirements against internal raw material specification and finished product specification as well as any special customer requirements.
- Log and maintain schedule of raw materials for testing 3 times to complete full approval. Responsible for annual testing schedule to keep in compliance against SOP and approval logs.
- Manage and log all product returns for rework material. Responsible for inspection of incoming material, sampling, testing if applicable, inspection of rework run, sample and release of materials. Keeping in constant communication with management on the return date and testing release dates in process and at completion.
Minimum Requirements
- Experience working within FDA and other regulatory agencies guidelines required
- Must have a high school diploma or equivalent.
- 3 years of work experience in QA/QC or a related technical field.
- A great communicator verbally and in writing.
- Excellent math, ready, and reading skills required.
- Basic computer skills needed.
- Must be willing to learn new tasks and procedures.
- Deadline driven, have a sense of urgency, and be proactive, possess excellent interpersonal skills, a professional attitude, and the ability to work independently as well as in a team environment.
- The ability to prioritize situations and tasks by importance.
- Other attributes including: Attention to detail, and the ability to respond to rapidly changing priorities and deal with multiple demands, good organizational and follow
We offer
- Competitive compensation and benefits, including 85% company paid Health Insurance and fitness membership
- PTO, and Paid Holidays
Job Type: Full-time
Pay: From $22.00 per hour
Expected hours: 40 per week
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- What is your expected pay based on your experience?
- Do you have a reliable car of your own to get to and work on time every day?
Education:
- Bachelor's (Required)
Experience:
- QC Supplements, Food, or beverage: 1 year (Preferred)
Work Location: In person
Salary : $22