QA Systems Specialist II

Published
November 14, 2021
Location
Webster, TX
Category
Job Type

Description

Experis, a ManpowerGroup company has an exciting contract opportunity for an QA Systems Specialist. This position is for one of our key clients, a global biopharmaceutical company that is engaged in the discovery, development and manufacturer of healthcare products.

If you are interested, Please reply back with an updated copy of your Resume.

Please find below Job Description:

Job Role: QA Systems Specialist

Location: Webster, TX 77598

Duration: 3+ Months (Possibility of extension)

Bachelor's Degree with emphasis on science / life sciences. EXPEREINCE - 2 to 4 years relevant Quality Systems experience, preferably working within an FDA regulated

manufacturing facility.

▪ Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal

documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies,

or members of the business community.

▪ Ability to effectively present information to management.

▪ Ability to define problems, collect data, establish facts, and draw valid conclusions.

GENERAL SUMMARY

The Quality Assurance Specialist II is responsible for maintaining quality oversight of operational areas by

working closely with operation's personnel and performing various checks during manufacturing processes.

They also assess regulatory and quality risks in activities and processes according to regulatory agency rules

and guidelines and the companies Standard Operating Procedures.

RESPONSIBILITIES

▪ Ensures compliance with all regulatory agency requirements and company specific regulations related to

quality of product.

▪ Reviews records to ensure they are complete, accurate and compliant with current Good Manufacturing

Practices (cGMP) requirements. Records include batch records and other documents involved in the

manufacture of drug product.

▪ Reports errors, deficiencies, discrepancies and observations to management. May stop operations when

product safety is or may be compromised.

▪ Performs Quality functions in classified areas, including checklists, aseptic intervention oversight, and

line clearances.

▪ Develops new material specifications upon request; revise existing material specifications when changes

are necessary.

▪ Works in collaboration with management team to prepare for internal and external auditors. Assists with

timely closure of audit observations.

▪ Conducts monthly/quarterly quality assurance audits for critical logbooks and required inspections of

classified areas.

▪ Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.

▪ Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP

through direct observation.

▪ Monitors operational processes by performing product changeover / room clearance inspections and

auditing work-in-progress then reporting results to proper management.

▪ Supports operational departments as needed to assure customer and regulatory requirements are met.

▪ Performs Root Cause assessment and suggests corrective action to prevent recurrence.

▪ Evaluates technology transfers associated with new products or processes.

▪ Willing to work flexible hours to support organizational needs.

EDUCATION/EXPERIENCE

▪ Bachelor's Degree with emphasis on science / life sciences.

▪ 2 to 4 years relevant Quality Systems experience, preferably working within an FDA regulated

manufacturing facility.

▪ Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal

documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies,

or members of the business community.

▪ Ability to effectively present information to management.

▪ Ability to define problems, collect data, establish facts, and draw valid conclusions.

Primary Recruiter: Saira Hasan
Recruiter Phone Number: 414-666-8462 Ext - 7168
Recruiter Email: [Click Here to Email Your Resumé]
Your LinkedIn (Link) linkedin.com/in/saira-mohammad-hasan-28480211a

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