CypressRecruiter Since 2001
the smart solution for Cypress jobs

Quality Manager/Senior

Company: United Exchange Corp
Location: Cypress
Posted on: March 25, 2020

Job Description:

United Exchange Corporation is an established and fast-growing manufacturer/distributor of health and beauty care consumer products. UEC is seeking a Quality Manager/Senior to direct all aspects of Supplier Quality Management Program including supplier qualification audits/assessments, product quality assessments, develop/approve Quality Agreements and maintenance of the Approved Supplier List. Duties and Responsibilities include, but not limited to: Interact with CMOs, Contract Laboratories, Supply Chain (Purchasing), regulatory personnel and with external counterparts at contract organizations to ensure compliance with the company quality policies, and documentation (ex: CAPAs) associated with development, manufacture and distribution of commercial products as per requirements of 21CFR Part 210/211/820. Manage the QA/QC activities for incoming products from contract manufacturers (CMOs). Manage the quality control testing activities at contract labs and oversee laboratory investigations. Prepare QC product specifications, and create/review/approve certificates of analysis. Approve product batch record reviews and evaluation process. Hands on management and support of QA activities including but not limited to batch clearance, quality hold and destruction processes. Conduct investigations (including customer complaint investigations), and root cause analysis. Initiate and implement CAPAs to address findings, issues and non-compliances in the facilities. Author, revise, and train on SOPs, protocols, forms, and work instructions as required. Manage/Direct training of internal personnel to ensure compliance to regulatoryrequirements/SOPs. Assure that Quality complies with cGMP, and other regulatory and industry standards. Manage the Stability testing at CMOs and contract labs, stability protocols and records. Oversee the transfer of methods to and from QC Labs and CMOs as needed. Review analytical and test method protocols and reports. Review a variety of analytical testing of raw materials and finished products. Experience with variety of laboratory equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, Viscometer, Moisture Apparatus, Melting Point apparatus, etc. Understand a variety of analytical lab tests in compliance with standard testing methods, procedures and regulations (USP). Continually evaluate quality systems supporting cGMP operations for potential improvements. Alert line management of significant quality, compliance, supply and safety risks, often requiring the coordination of activities across organizational units. Exercises independent judgment. Develop and prepare quality data/metrics for Management Review Maintain up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance. In-depth understanding and working knowledge of FDA and pharmaceutical cGMP regulations. Participate during FDA inspections, internal audits and CMO and laboratory audits. Must be detail oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanor with a high focus on quality and compliance. Possess leadership skills with the ability to develop employees and maintain an atmosphere of growth and achievement; a self-starter with minimum oversight required to accomplish goals. Must possess excellent communication and technical writing skills, strong interpersonal skills and the ability to work with others in a positive and collaborative manner; able to communicate with a sense of urgency to internal and external customers. Proficient in Word, Excel and PowerPoint with the ability to promptly learn and master inventory system/regulatory/compliance software. Required Education and Experience: Bachelor's degree in Chemistry, Biology, or related field. 8+ years QA/QC experience; 8+ years in pharma or dietary supplement industry. Experience in auditing CMOs and Laboratories and with FDA Inspections are preferred. Experience working with Contract Manufacturing Organizations (CMOs) are a plus. Experience working in in Pharmaceutical or OTC manufacturing environment. ASQ certifications are a plus.

Keywords: United Exchange Corp, Cypress , Quality Manager/Senior, Executive , Cypress, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Pizza Hut Shift Leader/Shift Manager
Description: 8011 UNIVERSITY AVE. LA MESA, CA 91941 Pizza Hut Shift Leader/Shift Manager br Description:Become your best and make hungry people happy as a Shift Leader for Pizza Hut--. You'll get the benefit of (more...)
Company: Pizza Hut
Location: La Mesa
Posted on: 04/9/2020

Case Manager RN Per Diem Days
Description: Fountain Valley Regional Hospital is proud of the full range of quality services we provide. Since 1971, we have dedicated our efforts to meet and serve the medical needs of our growing community. We (more...)
Company: Tenet Health
Location: Hacienda Heights
Posted on: 04/9/2020

Shift Supervisor Management Trainee
Description: Job DescriptionThe Shift Supervisor Trainee role is an entry-level, short-term role that prepares an employee to perform a higher-level supervisory role, such as Operations Supervisor or Shift Supervisor. (more...)
Company: CVS Health
Location: Poway
Posted on: 04/9/2020


Sales Manager
Description: Sales Manager Every employee with the Bakhtiari Automotive Group is absolutely critical to its success. We are a family-owned and operated business have been since the 1980s. Our rapid growth and
Company: Puente Hills Subaru
Location: Rowland Heights
Posted on: 04/9/2020

RN OR Surgery Clinical Manager Full Time Days $10k Sign On
Description: Lakewood Regional Medical Center is proud to be an integral part of the Orange County community. From orthopedics to cardiac care to urology, we ve received many designations for quality care. Although (more...)
Company: Tenet Health
Location: Fountain Valley
Posted on: 04/9/2020

Shift Supervisor Management Trainee
Description: Job DescriptionThe Shift Supervisor Trainee role is an entry-level, short-term role that prepares an employee to perform a higher-level supervisory role, such as Operations Supervisor or Shift Supervisor. (more...)
Company: CVS Health
Location: Hacienda Heights
Posted on: 04/9/2020

Director Surgical Services RN $20k Sign On Bonus Lakewood Regional Medical Center
Description: Lakewood Regional Medical Center is proud to be an integralpart of the surrounding community. From orthopedics to cardiac care to urology,we ve received many designations for quality care. Although we (more...)
Company: Tenet Health
Location: Fountain Valley
Posted on: 04/9/2020

Restaurant Manager
Description: Restaurant Managers Walk the talk and eat a Jumbo Jack-- with us. We know you have so much to bring to the table as a leader. Share your passion for food and life and motivate your team to pursue a better (more...)
Company: Jack In the Box
Location: Paramount
Posted on: 04/9/2020

Part Time Assistant Manager (1000 East Route 66 Avenue - Store 0345)
Description: Tuesday Morning is taking the lead in off-price retail offering upscale decorative home accessories, housewares, seasonal goods and famous-maker gifts. Our mission is simple offer fresh and exciting (more...)
Company: Tuesday Morning
Location: Glendora
Posted on: 04/9/2020

Director Telemetry RN Fountain Valley Regional Medical Center
Description: Fountain Valley Regional Hospital is proud of the full range of quality services we provide. Since 1971, we have dedicated our efforts to meet and serve the medical needs of our growing community. We (more...)
Company: Tenet Health
Location: Fountain Valley
Posted on: 04/9/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Cypress RSS job feeds