Quality Control Manager--Manufacturing

Quality Control Manager

Responsible for directing QA employees to perform the duties associated with QA and document control.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Includes the following, but other duties may be assigned as the company's needs dictate.

* Is responsible for assuring the quality of products before they are made available for sale, and has the training, experience, and technical knowledge to carry out these duties.

* Ensures that the necessary and relevant tests are carried out and that products are not released, until quality has been determined to be satisfactory by confirming that products specifications are met.

* Investigates and ensures that every complaint received in respect of the quality of products is recorded and corrective actions taken.

* Ensures that QA personnel are up to date in their duties as QA Inspectors and Specialists.

* Administers all QA/QC documents and the change control system.

* Ensures that any product returned for investigative purposes is properly disposed of at the end of the study.

* Assists QC Manager with FDA/Contract Manufacturer audits.

* Prepares annual batch record product reports.

* Issues new documents (SOPs, test methods, test sheets, batch records, master formula and spec sheets).

* Writes new SOP to maintain our companys compliance with current GMP regulations.

* Updates and/or changes documents as required and assures documents accuracy.

* Files and/or tracks training and follow-up for completeness.

* Reviews and/or audits batch records, issues batch records, and issues logbooks.

* Tracks status of manufacturing investigations, laboratory investigations, special projects, customer complaints, process changes, and CAPAs.

* Scans and files completed documents (i.e., special projects, manufacturing investigations, laboratory investigations).

* Ensuring that manufacturing processes comply with standards at both national and international level.

* Works with operating staff to establish procedures, standards, and systems.

* Approve or reject all formulation, procedure, specification, test method, controls and results that may affect the purity, quality of the product.

* Supervises QA personnel and reviews their performance.

* Approves or rejects product quality deviations and product reprocessing in the manufacture of a product.

* When the QC Manager or assistant is unavailable, the QA manager may perform some of the QC manager functions.

SUPERVISORY RESPONSIBILITIES:

Manages QA personnel. Is responsible for the overall direction, coordination, and evaluation of the Quality Assurance unit. Carries supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION and/or EXPERIENCE:

Masters degree (M.S.) in a scientific discipline from four-year college or university. Should have 5+ years of experience in Quality Assurance/Quality Control. Experience with batch record release, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility.

Compensation: $110K - $115K