25 days old

QA Associate

Kelly Services
Raritan, NJ 08869
QA Associate

Contract duration : 1 year Pay rate : 52 $/hour


Job Details

Manage Document Control activities and projects

Proactively evaluates and facilitates remediation of compliance risks

May participate in change control as owner, assessor or approver

Draft, edit and approve department procedures

Responsible for assuring compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is monitored and gaps are mitigated

May approve (or develop) cGMP training materials/plans for functional areas within JSC Stab Ops

Participate in Lean initiatives as applicable and assist in driving Quality, Compliance and Lean thinking throughout Stability Operations

May participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.

Provides training for Quality concepts or systems

Monitors non-conformance and commitment data for trends

Coordinates, maintains, reports and drives quality metrics

Maintains inspection readiness system and activities for the site

Participates in quality audits, inspection activities and responses.

May participate in investigations as owner, reviewer, process owner, creating and driving metrics, and performing Quality review and approval of records

Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, DEA, and OSHA

Manages timeliness of local investigations, CPA, Change Controls (e.g., tracks open records and assures closure)

Escalates issues to management in timely manner and works with management to address and remediate issues

Knowledge and Skill Set requirements include:

Knowledge and understanding of current Good Manufacturing Practices (cGMP)

Basic knowledge of analytical technologies used in the QC Stability laboratory

Knowledge of global regulatory and compendial (USP, EP, JP, etc.) requirements

Ability to manage an individual project with guidance from supervision/management

Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)

Ability to makes GMP decisions both independently and with occasional guidance from QA supervision

May occasionally assist the supervisor in establishing priorities

Ability to influence others successfully

Understanding of equipment qualification and computerized system validation processes and requirements

Understanding of analytical method validation and transfer processes and requirements

Proficient with Quality Systems for investigations/CPA management, change control, document management (e.g., Trackwise, ComplianceWire, DocSpace)

Ability to write and/or effectively review/critique technical documents such as lab investigations with analytical and regulatory content as it relates to stability operations

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-02-05 Expires: 2021-03-08

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QA Associate

Kelly Services
Raritan, NJ 08869

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