22 days old

Quality Project Lead (Pharma)

Kelly Services
Baltimore, MD 21217
Quality Project Lead (Pharma)


1 year W2 contract

CV-19 Vaccine Quality Project Lead

1. Summary of Assignment

a. Oversee all open investigations, batch release timing, and communicate quality

project lifecyle for the CV-19 Vaccine Quality function. The incumbent is the

Account Managers right hand.

2. Key Responsibilities

a. Provide quality support for the Vaccine External Manufacturing site.

b. Ensure effective and compliant execution of quality systems at the EM sites.

c. Participate in deviation review, development of corrective action plans, and

monitor implementation

d. Provide cGMP compliance support to EM by investigating and resolving quality


e. Coordinate and provide concurrences on deviations

f. Monitor quality performance of EM

g. Work closely with the Account Manager, Person in Plants, Batch release

personnel and partner with the CMO to deliver business and quality goals with


h. Author, revise, review, and approve Quality System documents

i. Maintain oversite for status of individual batches, including sampling, testing,

deviations, and target release timelines; communicate status accurately and


j. Develop tracking mechanisms for internal and external investigations

k. Gather daily updates from External Manufacturers regarding investigations and

batch releases across entire quality project lifestyle

l. Daily query to analyze and understand any project needs/investigations

m. Track timeliness of quality needs and raise awareness of those coming due

n. Facilitate daily triage meetings with in-depth understanding of current quality


o. Ensure appropriate quality processes is followed and all documentation complete

p. Communicate and manage any notifications to appropriate parties

3. Required Experience/Knowledge

a. Bachelors degree with a concentration in engineering, science, or an equivalent

technical discipline

b. Knowledge and experience with aseptic process operations or quality assurance.

c. Experience in quality investigations and quality systems


d. Strong interpersonal and written/oral communication skills to include information

sharing with senior leaders

e. Fundamental knowledge of drug manufacturing processes

f. Experience in a regulated environment

g. Experience with project management

h. Good organizational capabilities

i. Professional proficiency in English

j. Microsoft programs

4. Preferred knowledge:

a. Vaccines production

b. Working with external manufacturers

Onsite with some flexibility working remote

**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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: 2021-04-21 Expires: 2021-05-22

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Quality Project Lead (Pharma)

Kelly Services
Baltimore, MD 21217

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