Overview
QA Line Inspector Jobs in San Fernando, California, USA at PureTek Corporation
The Quality Assurance Line Inspector works under the general direction of the QA Manager and is responsible for the assigned day-to-day functions within the Quality Assurance department. Ensuring compliance with current Good Manufacturing Procedures (cGMPs), the company’s Standard Operating Procedures (SOPs), and regulatory guidelines; and preparing management reports as requested. Uses discretion to make independent decisions, applying knowledge of industry best practices, cGMPs, SOPs, and regulatory requirements.
Essential Responsibilities:
Inspects and issues reports of all packaging finished goods using established protocols.
Bottles, Labels, Stickers, Seals, Shippers, Pads, Caps, Sleeves, Cello bands, Unit Cartons, Tubes, Sprayers, etc.
Audits item number versus description.
Inspects against standards.
Creates standards for approval as needed.
Submits samples to the laboratories as required for product approval.
Checks and inspects the quality of filled product during the in-process and compares against the standard.
Checks the quality, height, and weight of the bottles and crimp of the tubes.
Checks the bar code.
Maintains retain Log Book.
Applies release stickers on pallets of finished goods.
Prepares daily reports of in-process packaging product.
Imprints quarantine stickers and places them on the pallets.
Estimates the yield of the batches as per protocols and closes the reports.
Supports other areas of the department:
Audits batch records.
Processing checks for uniformity.
Filling.
Line inspection.
Special orders.
Maintains cleanliness and good housekeeping in work area including tools used.
Assists in physical inventory counts as requested.
Performs other duties assigned by supervisor.
Reviews and finalizes batch records.
Releases batches for shipment.
Processes Questionable Material Reports (QMR), Material Destruction Records (MDR), and Reprocessing Orders (RO) as needed.
Reviews and approves SOPs and other QA related documents.
Conducts internal audits and participates in client and regulatory agency audits.
Maintains appropriate QA records and documentation.
Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff, vendors, and outside agencies.
Adheres to company policies and procedures and sets a positive example for others within the organization.
Establishes priorities to ensure timely job completion.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Discretion in handling confidential and sensitive matters.
Knowledge of drug cGMPs, SOPs, and regulatory guidelines including FDA requirements.
Knowledge of QA industry best practices.
Education, Experience, and Licensure:
Bachelor’s degree in Science (chemistry, pharmacy, or biology) or equivalent work experience.
Technical Skills:
Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.
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Title: QA Line Inspector
Company: PureTek Corporation
Location: San Fernando, California, USA
Category: Quality Assurance – QA/QC (Data Analyst)
