Jobs in the United States

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Added 1 min ago
Training Representative - GI Access
Duke Careers
Durham, NC
The Training Representative for the GI Access Center is responsible for the onboarding, training, and continued development of all scheduling staff specifically for the GI Access Center.…
Added 1 min ago
Community Engagement Manager
Barnabas Center Inc
Fernandina Beach, FL
…interested in supporting Barnabas Center general operations and program areas. Working with the Development team and the Barnabas Ambassadors program, the Community Engagement Manager…
Added 1 min ago
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Case Manager --Rapid Rehousing Plus Care
Volunteers of America Colorado
Denver, CO
- $22 to $24 USD / hour
Case Managers for the Rapid Rehousing Plus Care (RRH+C) program are directly responsible for the service provision and housing assistance for program participants. RRH+C serves individuals…
Added 1 min ago
VO
Bilingual Case Manager: Community Housing Programs
Volunteers of America Colorado
Denver, CO
- $22 to $24 USD / hour
…responsible for the service provision and housing assistance for program participants. This position will work for VOAC’s Rapid Rehousing Plus Care (RRH+C) program and the Shelter into…
Added 1 min ago
VO
Case Manager: Community Housing Programs
Volunteers of America Colorado
Denver, CO
- $22 to $24 USD / hour
…responsible for the service provision and housing assistance for program participants. This position will work for VOAC’s Rapid Rehousing Plus Care (RRH+C) program and the Shelter into…
Added 1 min ago
Senior Project Engineer
Skanska USA
Raleigh, NC
Compensation and financial well-being – Competitive base salary, 401k, & Employee ownership program.
Added 1 min ago
SU
Director - Corporate Accounting
Skanska USA
Arlington, VA · Parsippany, NJ
- $185,000 USD / year
Added 7 mins ago
Sales Representative
Westgate Resorts
Vancouver, WA
As a Vacation Sales Representative, you’ll turn dream vacations into reality through conducting face-to-face presentations and sharing the exciting benefits of our flexible points-based…
Added 7 mins ago
WR
Front Desk Agent
Westgate Resorts
Kissimmee, FL
- Up to $16.5 USD / hour
…essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable…
Added 7 mins ago
CO
Senior HR Compensation Analyst
City Of Chattanooga
Chattanooga, TN
- $65,304 to $78,895 USD / year
…duties performed by all employees in this classification, only a representative summary of the primary duties and responsibilities. Incumbent(s) may not be required to perform all duties…
Added 9 mins ago
H
Woodlands 05 (Kuykendahl/Creeks) Seafood - Perishables Rep - Part time
HEB
Tomball, TX
- Part-time
Responsibilities Job Summary: As a Perishable Representative, you are responsible for providing a well-stocked and well-maintained department while providing superior customer service. You…
Added 9 mins ago
Bakery Clerk
Festival Foods
Green Bay, WI
…job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with…
Added 11 mins ago
Professor
North Carolina State University
Raleigh, NC
…Science Department has a highly successful e-Partners industrial program with major Fortune 500 companies as its e-Partners contributing to student projects, career opportunities, academic…
Added 11 mins ago
Digital Marketing Specialist
The AMES Companies, Inc.
Orlando, FL
We have amazing Benefits! Medical, Dental, Vision, Life Insurance, Wellness, 401K, Holidays Employee Assistance Program, Vacation Days, Disability, and much more.
Added 13 mins ago
Patient Account Representative I - Customer Service
Halifax Staffing Inc.
Daytona Beach, FL
Patient Accounting Representative assist patients, guarantors and third parties on accounts to resolve any questions or concerns towards satisfying account balances with patient/third party…
Added 14 mins ago
System Product Design Engineer
Apple
Cupertino, CA
…safety, and human fit through mechanical design. Design bio-representative human heads for safety impact…
Added 16 mins ago
P
Diesel Technician/Mechanic III - Entry Level
Penske
Conklin, NY
- $24 USD / hour
Strong, well-rounded training on a variety of OEM equipment (Penske’s Technician Certification Program is certified as a Continuing Automotive Service Education provider)
Added 17 mins ago
TriStar JCB - Parts Delivery Driver
JCB North America
Murfreesboro, TN
…and offering a highly competitive compensation and benefit program to ambitious candidates who possess the desire and mentality to excel at both the personal and professional levels.…
Added 17 mins ago
TriStar JCB - Parts Delivery Driver
JCB North America
Murfreesboro, TN
…and offering a highly competitive compensation and benefit program to ambitious candidates who possess the desire and mentality to excel at both the personal and professional levels.…
Added 17 mins ago
TriStar JCB - Parts Delivery Driver
JCB North America
Murfreesboro, TN
…and offering a highly competitive compensation and benefit program to ambitious candidates who possess the desire and mentality to excel at both the personal and professional levels.…
Added 18 mins ago
AS
Community Habilitation Worker + Respite Worker - Woodside, Queens NY
Access: Supports for Living
Queens, NY
- $17 USD / hour
Adhere to all Agency and Program Policies and Procedures, including HIPAA, Confidentiality and implementing the Corporate Compliance Plan and related policies and procedures.
Added 21 mins ago
Parts Business Development Representative
The Raymond Corporation
Louisville, KY
Raymond Storage Concepts (RSC) is looking for a motivated, results-driven Parts Business Development Representative to help expand our parts business throughout the Louisville, Kentucky…
Added 21 mins ago
Elementary School Teacher
Cabarrus County School District
Concord, NC
Performs difficult professional work providing a broad range of teaching services or specific learning program, assisting students to develop skills, attitudes and knowledge needed as a…
Added 23 mins ago
Bakery Clerk
Festival Foods
Green Bay, WI
…job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with…
Added 23 mins ago
Quality Engineer
Stokes Pharmacy
Mount Laurel Township, NJ
Maintain CAPA program for equipment and facilities.

Stokes Pharmacy

Quality Engineer

Mount Laurel Township, NJ, United States

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Job details

Posting language: English

Original job description

Summary/Objective This position requires an individual who can work within a cGMP environment in collaboration with Quality Assurance, Quality Control, Manufacturing, and Distribution. This includes building expertise, establishing predictable and consistent processes, focusing on business priorities, and accelerating new technologies/processes. The successful candidate must be focused on achieving company goals while sustaining a continuous improvement culture at Epicur Pharma.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Serve as an SME on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDocP).
Identify continuous improvement opportunities throughout the organization by routinely studying, prioritizing, and selecting projects that leverage lean manufacturing.
Develop and utilize tools to identify KPIs to drive continuous improvement and manage weekly/monthly site reporting for Personnel, Safety, Quality, and Manufacturing.
Facilitate advanced problem solving and analysis of specific improvement opportunities leading to the implementation of effective sustainable solutions.
Promote the use of data and metrics for identifying improvement opportunities and problem-solving activities.
Engage with teams to help establish a Continuous Improvement culture and execute advanced problem-solving activities.
Perform and assist in investigations and lead development of CAPAs.
Maintain CAPA program for equipment and facilities.
Assist in development and execution of cleaning validations for relevant manufacturing equipment.
Develop or collaborate on URS and FDS documentation for relevant projects.
Support design, development, and delivery of training and project execution.
Assist in the identification and sharing of best practices across the organization.
Assist in maintaining all equipment, facilities, and utilities, in the relevant compliant state, during changes and routine review as related to activities. This includes summary reports and/or periodic review that must be documented for each piece of equipment and utility.
Assist in maintaining equipment database for tracking routine and non-routine maintenance/calibration activities.
Lead in the development and implementation of new and revised policies/procedures.
Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
Perform quality review of related validation/qualification documentation and processes for other departments.

Required Education and Experience

Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred
Minimum 2 years of experience in pharmaceutical/cosmetic manufacturing environment or related field, with degree
Minimum 4 years of experience in pharmaceutical/cosmetic manufacturing environment or related field, without degree
Familiar with GMPs, FDA, ICH, OSHA requirements
Familiar with 21 CFR Part 11, 210, 211, and 820
Familiar with ICH Q7, Q8, Q9, and Q10
Experience using Minitab, Excel, and/or relevant applications
Must have knowledge of basic principles, theories and laws, policies and procedures that pertain to compounding
Must have strong organizational skills and exceptional attention to detail
Must exhibit punctuality and low absenteeism
Able to work independently, as well as part of a team
Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
May need to lift up to twenty-five (25) pounds on occasion

Eligibility Qualifications

Must be capable of wearing all protective wear as required by Company Safety Policies. This includes, but is not limited to, mask, gloves, gown, hairnet, safety goggles, etc.
Must be able to work with chemicals used in the preparation of compounds following any special safety precautions as required.

Competencies

Communication Proficiency
Decision Making
Detail Oriented
Time Management
Problem Solving/Analysis
Quality Oriented
Results Driven
Technical Capacity

Supervisory Responsibility This position has supervisory responsibilities of the Quality Assurance Department. Work Environment This job operates primarily in an office and a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking.

Language Skills Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Able to sit and/or stand 8-10 hours or more per day as needed
May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed
Finger dexterity to operate office equipment required
Ability to lift up to twenty-five (25) pounds on occasion

Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times.

Travel No travel is expected for this position.

Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.

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