Job Details

Requisition Number 20-0051
Post Date 2/14/2020
Title Quality Assurance Supervisor
City Orangeburg
State NY
Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

Coordinate the workload of QA inspectors across multiple shifts and be primarily responsible for completion of investigations into non-conforming Finished Goods in a timely manner.


ESSENTIAL FUNCTIONS AND BASIC DUTIES

This position is responsible for supporting the execution and maintenance of key Quality projects and programs within the New York Site QA/QC organization. Other key accountabilities specific to the NY Site QA function include:
1. Finished Good Inspection on the production floor, Document Review, Complaint/NCR Investigation, CAPA support, and special projects, as assigned.
2. Key interfaces include: Site QA and QC personnel, Research and Development, PDII Manufacturing and Operations, and Corporate Quality.
3. This position will be responsible for supporting the coordination as well as conducting complaint investigations in support of NY Site Quality and Corporate Quality Systems. This individual will interact with Senior Management across all disciplines.
4. Support coordination, investigation, and management of all complaints issued to the NY site in support of Corporate Quality Systems.
5. Manufacturing Nonconformance investigation closeout and log maintenance
6. Ensure that documentation moves through the approval process on a timely basis.
7. Act as back up for the Quality Assurance Manager, wherever needed.


PERFORMANCE MEASUREMENTS
1. On time completion of investigations
2. First time right paperwork (inspection records, investigations, etc)
Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION: Bachelor’s Degree or equivalent experience

REQUIRED KNOWLEDGE:
 Working knowledge of 21 CFR 211, 820, and/or ISO 13485, cGMP’s
 Thorough knowledge of the complaint/nonconformance process, including investigation and root cause analysis
 Proficient in Microsoft Office platforms

EXPERIENCE REQUIRED:
• 3-5 years’ experience in regulated manufacturing setting desired

SKILLS/ABILITIES:
• Ability to handle multiple projects at once, well developed writing skills,and ability to interact with senior management


WORKING CONDITIONS

NONE: No hazardous or significantly unpleasant conditions.

#LI-PDI
#LI-SC2


INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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