Quality Assurance Inspector Position Available In Suffolk, New York

Quality Assurance Inspector 3.0 3.0 out of 5 stars Hauppauge, NY 11788 At Country Life, we inspire greatness through our wholistic approach of supplement and personal care products. Our team of experts, innovators and dreamers is dedicated to bringing the power of nature and the promise of science to people at every life stage. Join our Hauppauge, NY team and share our passion for natural health and pride in our company’s commitment to excellence and quality!

Position Summary:

Coordinates and performs all incoming inspections of components and finished products in accordance with cGMPs and Standard Operating Procedures as per the regulatory requirements.

Position Responsibility:

Manufacturing –

QA Inspection:

Checks batch record for accuracy, e.g., lot number, batch size, number page, required signatures. Releases batch record to pharmacy who then returns batch when complete. Performs routine clearance of equipment as stated in the Standard Operating Procedures (SOP) and notes in the log book after each batch is completed, e.g., encapsulation, tablets and powders. Releases batch record to blending, two samples are taken. Makes labels and then the samples are submitted to the lab. Checks process against documents. Performance checks on done on capsules and tablets by checking from start through approval and then checking physical parameters to the master formula. Performs periodic checks during each batch process. If coating is required then approval given to transfer to coating area. Submits finished batch to lab for approval and release in the system. Turnover performed with next shift to report any problems and/or remaining work to be performed. Packaging –

QA Inspection:

Checks work order against the label for component specifications. Performs line clearance as stated in the SOP. Ensures material handler has delivered the correct product and lot number for packaging line. Checks first piece and last piece packaged to ensure proper count, correct label, etc. and prepares documentation paperwork. Performs periodic in process inspections during packaging process and documents. Secures packaging area from any foreign materials prior to packaging and ensures area is clear at all times. Supervises third party runs as needed. Record Documentation  Copies master batch records as per planning requirements and photocopies the master batch record and issues the record. Receives third party finished products and releases and sends the sample for lab testing. Notifies packaging of product release. Manually combines manufacturing and packaging batch records after completion of the total batch packaging. Checks calculations and signatures per cGMP standard Once batch is released, Quality Control generates the release of paperwork in system and files batch record. Sampling Samples all incoming raw and bulk materials and finished products for the chemical and physical specifications. Prepares all materials necessary to be sampled / inspected. Matches the name, lot code and inspects for defects in batch, e.g., physical appearance, smell, consistency problems, etc. Assists in pulling records from retention as well as locating the retrieving retention samples from warehouse. Data enters lot number and transfers by batch and if accepted certifies the batch. Takes a testing sample and submits it to Quality Lab. May assist in the daily internal calibration of laboratory equipment such as scales, balances. Assists in proper disposal of retention samples once laboratory testing is complete. Prepares sampling record of raw materials and bulk. Quality Assurance Inspectors are cross trained in all inspection procedures for Manufacturing, Packaging, Batch Record Documentation and Sampling, e.g., hardness tester, calipers, thickness gauge, DT – Disintegration machine balance and hand tools. Physical duties such as lifting / moving bags up to 60 lbs. laterally while sampling, lifting actual samples from sampling cart to laboratory sample area, moving retention samples from warehouse to the required laboratories, using a cart on wheels. Rolling drums for sampling.

QUALIFICATIONS

Experience and Skills:

1 year inspection experience in an FDA regulated industry; 4 years for Lead Good organization skills Good interpersonal skills Working knowledge of PC software, MS Office, Word, Excel Excellent written and verbal communication skills including English Good mathematical skills.

Education and Certifications:

High School Diploma plus 2 years work related experience

Job Type:

Full-time Pay:

From $19.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Referral program Vision insurance

Schedule:

8 hour shift

Work Location:

In person