Lead QA Documentation Specialist - Orangeburg, United States - PDI

PDI

Verified Company

Orangeburg, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness.

Encompassing three 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

The Lead, QA Documentation Specialist is responsible for overseeing the daily quality assurance process, ensuring successful product releases, and managing the timely issuance, reconciliation, review and release of production records, including the creation of Certificates of Analysis (COAs) and Certificates of Compliance (COCs).

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Maintain the master log of item numbers for all finished products, components, and chemicals
Create the bill of materials from approved job sheets and maintain Bill of Material specifications in the ERP system
Issue batch manufacturing documents per Shop Orders and reconcile the batch manufacturing documents
Ensure all opened issues are addressed before release and work with crossfunctional teams to identify and mitigate risks associated with releases
Control manufacturing shop order master specifications to ensure the current revision is available to Production
Provide regular updates on the testing process and release status to stakeholders
Act as an Authorized Person for the release for supply of medicinal products, maintaining qualifications as required
Interact with internal departments, business units, and outside laboratories to organize, review, and analyze data pertaining to batch release in compliance with procedures and regulatory requirements
Review and approve routing Bill of Materials and Manufacturing Instructions in the Document Management System
Mentor and train team members on best practices and processes related to Quality Assurance
Ensure compliance with all regulatory requirements and industry standards
Maintain the certificate request mailbox
Support investigations, audits, and inspections as required
Perform other duties as assigned

PERFORMANCE MEASUREMENTS

Ontime release of products
Firsttime right review of production jackets
Ontime completion of all training

QUALIFICATIONS

EDUCATION/CERTIFICATION:

Bachelor's degree in Chemistry, Analytical Chemistry, other related science

REQUIRED KNOWLEDGE:

Proficiency in Microsoft Office Suite (Outlook, Word, Excel)

EXPERIENCE REQUIRED:

Minimum of 5 Years of experience working in regulated industry

SKILLS/ABILITIES:

Excellent communication and leadership skills.
Strong analytical and problemsolving abilities.
Ability to work independently and as part of a team.
Attention to detail and ability to manage multiple tasks simultaneously.

WORKING CONDITIONS
No hazardous or significantly unpleasant conditions

SALARY RANGE
- $60,000 - $65,000 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 inform