13 days old

Quality Assurance Specialist

Kelly Services
Ledgewood, NJ 07852
**Seeking a Quality Assurance Manufacturing Specialist to work with our Pharmaceutical client in Ledgewood, NJ!**

Our Client is an innovative, fast-growing pharmaceutical company in Ledgewood, NJ. They are one of the nations leading ophthalmology compounding businesses with dispensing facilities based in Ledgewood, NJ. Their 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP); the highest federal quality standards for drug manufacturers in the country.

**Sound like a team you'd like to join? Read more below!**

Title: QA Manufacturing Specialist

Location: Ledgewood, NJ

Duration of Employment: Direct Hire; Full-Time

Hours: Multiple Shift Options Available!!

1st Shift (5AM to 1:30PM)

2nd Shift (1PM to 9:30PM) Mon-Fri; Weekends Occasionally (Based upon company Need)

**_Pay: $28/HR_**

**_Vaccination is REQUIRED._**

Job Duties:

+ Oversight and confirmation of compliance in Compounding processes including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, autoclave, compliance with batch record instructions and sequence, documentation verification, GMP documentation verification.

+ Oversight and confirmation in compliance of Filling Operations including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms and batch records.

+ Verification of proper gowning by all personnel in all areas of Production.

+ Verification of environmental monitoring activities including plating, Lighthouse and personnel monitoring.

+ Generation of deviations, issuance of CAPAs, Change Controls in response to observations

+ Follow up with Quality Assurance Management on quality issue tracking and trending activities also include batch record review, batch release, visual inspection and any other activity assigned by Quality Assurance management.

+ Oversee all Quality aspects on the floor

+ Product label review and approval

+ Participate in regulatory audits

+ Performs or assists process owners with root cause analysis

+ Prepares and monitors Quality Metrics and KPIs

+ Performs duties in accordance with established company procedures and policies; performs other duties as assigned.

Qualifications and Experience

+ MUST have 3+ years of experience with aseptic drug product manufacturing

+ MUST have a flexible work schedule

+ MUST have 3-5 years of progressive experience within cGMP quality operations and FDA regulations OR a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience.

+ MUST have a high school degree/GED

+ BS in Scientific field preferred but NOT required

+ Ability to complete tasks with little direction or need for supervisory follow-up.

+ Strong written, verbal and presentation communication skills.

+ Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other - must be able to learn additional software as required).

+ Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.

+ Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.

**Applications are being accepted NOW - DON'T WAIT!!!**

**Apply Today!**

After you apply, please send your updated resume to ! I will reach out to you as soon as possible!

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

Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.

**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: 2022-06-15 Expires: 2022-07-16

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Quality Assurance Specialist

Kelly Services
Ledgewood, NJ 07852

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