WI3667368

1

Bachelor's Degree

Bachelors Degree

First Shift (Day)

40

JOB REQUIREMENTS: Manager, Analytical Quality Lab - MANAG003621
DESCRIPTION/RESPONSIBILITIES: Key Responsibilities:
Supervision/Coordination: \* Manage staff including interviewing,
hiring, training, and developing employees; planning, assigning, and
directing work; appraising performance; rewarding and disciplining
employees; addressing complaints and resolving problems. \*
Independently set clear direction for all direct reports consistent with
departmental needs. Quality Testing: \* Evaluate and implement new
analytical technologies per Quality System Standards, Quality System
Regulations, and other company procedures around which the Quality
System is developed. \* Ensure completion of all testing, including raw
materials, in-process, final release, stability, environmental,
biological, and special project/protocol testing in a timely manner that
achieves fulfillment to commitments. \* Ensure lab investigations are
timely and in compliance with current regulatory standards and
expectations Support Manufacturing: \* Serve as a resource for
manufacturing to determine best course of action and material
dispositions for investigations and unexpected occurrences. Quality
System Support: \* Lead investigations associated with product
deviations, product non-conformances, CAPAs, scrap and rework, and
analyzing the data for the reasons of Quality Improvement. \* Identify
and implement new quality improvement initiatives / projects in
accordance with cGMP / cGLP expectations to improve compliance, quality
levels (reducing defects), and improve operational efficiencies. \* Work
with manufacturing and other functional groups on manufacturing
regulatory compliance issues. \* Lead training program by developing,
coordinating, and delivering assigned training tasks. \* Serve as a
liaison with the Quality, Operations, Commercial, and Project Team
members. \* Update and communicate all needed issues as appropriate to
facilitate understanding and rapid decision-making. \* Participate in
product development and technical transfer teams as a subject matter
expert on testing and quality matters. Audit Support: \* Participate in
external audits as a subject matter expert on test method, test method
validation, and test method development. Quality Assurance: \* Perform
internal and vendor quality system audits. \* Perform routine
walk-throughs and compliance checks to verify adherence to quality
guidelines. Interact with inspectors in regulatory audits to represent
area of responsibility. Budgeting: \* Adhere to established expenditure
controls to support management of laboratory budget. Benefits: \*
Comprehensive Medical, Dental, and Vision plans \* 20 days of Paid Time
Off \* 15 paid holidays \* Paid Sick Leave \* 401(k) \* And more! Your
benefits and PTO start the date you\'re hired with no waiting period!
Come join a company that is committed to being a trusted partner focused
on our customers while not forgetting about our employees! 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 60-1.35(c) Equal Opportunity
Employer-minorities/females/veterans/individuals with
disabilities/sexual orientation/gender identity \*\*\*\*\* OTHER
EXPERIENCE AND QUALIFICATIONS: REQUIRED SKILLS: Quality Education: \* BS
in Physical Science or related field. Required \* Advanced degree (MS,
PhD, etc.) in a physical science field. Preferred Experience: \* GLP/GMP
experience. Required \* At least 5 years\' experience Pharmaceutical or
Medical Device Laboratory. Required \* Supervision/leadership
experience. Preferred Knowledge, Skills and Abilities: \* Familiarity
with cGMP regulations and FDA/USP/EP/BP/ICH guidelines. Required \*
Quality experience may include quality testing (analytical
chemistry/microbiology), QA/Regulatory, or Validation. Required \*
Experience with FDA, European agency regulations, cGMP regulations,
Laboratory Information. Required \* Knowledge of quality systems,
quality techniques, current regulatory requirements and technical issues
resolution. Required Must be able to pass vision testing requirements
(with or without corrective eyewear). - 20/20 Near Acuity Vision
\*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
https://ars2.equest.com/?response_id=fa8dce06570d05be3005699a38ebf852
Other: Applicants ONLY to apply via URL link provided!