Job Information
Kelly Services QA Associate II in Skillman, New Jersey
Quality Assurance Associate II
Montgomery Country, PA
Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We are currently interviewing and hiring immediately for an experienced Quality Assurance Associate II to join a global pharmaceutical, R&D, and medical device leader in Montgomery County, PA .
SUMMARY
The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance, and other departments as it relates to site Quality Assurance responsibilities.
RESPONSIBILITIES
Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing, and packaging lines.
Provides leadership support to QA Shop Floor activities including communication of quality events to management.
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
Provides support to Consumer Complaint investigations.
Provide QA support to various project teams, as needed.
Actively supports Site metrics, compliance improvement and training initiatives.
QUALIFICATIONS
B.S. or B.A. College Degree (Science or Technical Degree preferred)
3-5years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement
Active cGMP Interpretation and Application Experience
Demonstrated leadership- possesses the ability to lead a team
Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
Experience with Liquid Dose processing and packaging technology preferred.
Validation Experience preferred
Expertise in Handling Multiple Priorities
P#1
Send your resumes: Jacqueline.sayoc@kellyscientific.com
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.