Documentation Specialist - Orangeburg, United States - PDI

PDI

Verified Company

Orangeburg, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

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
Documentation Specialist responsible for timely review and release of production records and creation and of COA/COC.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Responsible for the following tasks:

Assigning finished product item numbers, component item numbers and chemical item numbers.
Maintaining the master log of item numbers for all finished products, components and chemicals.
Creating the bill of materials from approved job sheets.
Creating and maintaining the Bill of Material specification in the ERP system BPCS from approved job sheets/EICs.
Issuing shop orders.
Controlling manufacturing shop order master specifications and to ensure that the current revision is available to Production.
Accountability and release of sterile products.
As Authorized Person for release for supply of medicinal products, maintains qualifications to be authorized by PDI (a TGAapproved manufacturer). Release for Supply means certification by an Authorized Person that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorization and any other regulations relevant to the production, control and release of medicinal products.
Interacting with internal departments and business units and outside laboratories to organize, review and analyze data pertaining to the release of batches in compliance with procedures, product specifications, and applicable regulatory requirements including Marketing Authorization, where applicable.
Reviewing and approving routing Bill of Materials and Manufacturing Instructions in the Document Management System
Creating and posting of Certificates of Analysis (COAs) from LIMS onto the LAN
Maintenance of certificate request mailbox
Supports Investigations, Audits, and Inspections, where required.
Performs other duties as assigned.

PERFORMANCE MEASUREMENTS

On time release of product
First time right on review of production jackets
On time completion of all training

QUALIFICATIONS

EDUCATION/CERTIFICATION:

Bachelor's degree or equivalent experience

REQUIRED KNOWLEDGE:

Proficiency in Microsoft Office Suite

EXPERIENCE REQUIRED:

35 Years of experience working in regulated industry

SKILLS/ABILITIES:

Excellent organizational skills, and ability to interact with cross functional teams throughout the organization

WORKING CONDITIONS

No hazardous or significantly unpleasant conditions

SALARY RANGE
- $55,000 - $60,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

Medical, behavioral & prescription drug coverage
Health Savings Account (HSA)
Dental
Vision
401(k) savings plan with company match and profit sharing
Basic and supplemental Life and AD&D insurance
Flexible Spending Accounts (FSAs)
Short & longterm disability
Employee Assistance Program (EAP)
Health Advocacy Program

PDI also offers many voluntary benefits such as:Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

LI-PDI

LI-ONSITE

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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 c)