G&W Laboratories Quality Operations Specialist in South Plainfield, New Jersey

Who We Are

Since 1919, G&W Laboratories has made a portfolio of pharmaceutical products trusted by America’s healthcare institutions, pharmacists, and medical professionals. We are a family-owned and operated company committed to the best in healthcare through the development, manufacturing, and marketing of Rx and OTC specialty pharmaceuticals. We continue to expand our reach through new product launches, and strategic partnerships and acquisitions. To achieve our business objectives and fulfill our company mission, we depend on the support and contribution of high caliber employees.

Your Potential

At G&W, we are committed to Helping People Realize Their Potential™. A large part of that commitment is directed toward our employees—our most valuable asset and the foundation of our many achievements in our nearly 100 year history. G&W is a dynamic and growing organization, which creates opportunities for employees to advance and grow along with the company. We embrace change to maintain a leadership position in our industry, which allows us to provide our employees with an exciting and dynamic career experience. We have a unique history, a promising future, and an exciting "every day" as we consistently diversify and expand our product portfolio, our geographic presence, and our talented and strategic work force. We are committed to the continual development of our employees and to providing them with opportunities to grow and realize their potential.

Position Summary:

Position is responsible for quality review, release and issuing of documents related to the production of finished pharmaceutical products. This position will also support day to day floor inspection (line clearance, inspections, review of documentation, etc.) and bulk sampling as well as incoming inspection activities. Position will also be the functional lead for Annual Product Reviews.

TravelRequirements: 0%

EssentialDuties & Responsibilities

1.

Issue batch records and lot numbers for production. Ensure all batch records are complete with all required documentation and ready for auditing.

2.

Audit manufacturing and packaging batch records for completeness, accuracy, deviations and conformance to established methods, procedures and GMPs.

3.

Lead Annual Product Review program by coordinating with all functions and writing/preparing all product reports.

4.

Perform other duties as assigned.

5

Maintain proper documentation as per GMP. Maintain up to date training per GMP.

Position Requirements

Education Required:

Associates or bachelor’s degree in related science or technological field.

Education Preferred

N/A

Experience Required:

Minimum of 2 years of quality experience in pharmaceutical/regulated industry.

Experience Preferred:

Experience with batch record auditing and/or inspection activities

Specialized or Technical Knowledge Licenses, Certifications needed:

Experience with technical writing

Functional Knowledge:

· Familiarity with ERP (Oracle)

· Good Documentation Practices

· Data Integrity

· Sampling and visual inspections

· Basic GMP auditing techniques

Company/Industry Related Knowledge:

· GMP & GDP Regulations

1.

Basic understanding, knowledge, and experience with Quality Assurance Operations, GMP/GDP in regulated environments.

2.

Basic knowledge and understanding of document control and issuance in a regulated environment.

3.

Understanding of data integrity compliance.

4.

Basic Experience with application and use of ERP systems.

5.

Must be able to physically perform sampling, including bending and lifting up to 15 lbs. and using thieves.

6.

Customer focused, initiative, interdependent partnering.

7.

Possesses strong documentation, organizational and communication skills.

8.

In-depth understanding of good documentation practices in a GMP environment.

9.

Demonstrates ability to multi-task and excel in a highly timeline driven and dynamic fast-paced environment

Executes assigned tasks accurately and within pre-established timelines.

10.

Complies with company policies, procedures, rules and regulations.

11.

Engage and maintain in a safe and clean work environment by following current good manufacturing practices (cGMP), housekeeping and safety audits (ie. 6S program), and standard operating procedures.

12.

Exhibit the G&W Laboratories Core Values of Ethics, Unity, Humility, Gratitude, Service, Integrity, Fortitude, Respect, Faith, and Growth through all aspects of our performance and leadership while conducting any activities associated with the entity of G&W Laboratories.

Job-specific Competencies

Equal OpportunityEmployment

Providing “equal employment opportunity” is one of the most important people policies of G&W Laboratories, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all personnel decisions are in accordance with these principles of equal employment opportunity. Equal employment opportunity is not only a legal principle; it is a moral commitment we practice at G&W.

Job: Quality

Title: Quality Operations Specialist

Location: NJ-South Plainfield

Requisition ID: 170000186