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Pharmacy Manager - Community

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$66.75 - $78.50/hr

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Pharmacy Manager - Community

Juneau, AK ยท On-site

$69 - $81/hr

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Cook - Per Diem

Worcester, MA ยท On-site

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QA Validation Specialist 3

QA Validation Specialist 3

Lancesoft

Portsmouth, NH โ€ข On-site

Full-time

This job post hasย expired today.ย Applications are no longer accepted.


Job description

Notes from intake - Role is Equipment validation and Cleaning Validation
Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly Drafting SOPs
Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient). Looking for the worker to Build Equipment Requalifications in Kneat.



  • Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.



  • Drive/own the validation plans and execution of equipment changes and process improvements.



  • Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.



  • P erfo r m E q u i p m e n t V a l i d a t i on a c t i v i t i es t o i n c l u d e V a li d a t i on M a i nt e n a n c e Q u a l i ty S ys t e ms re v i ew a n d r e q u a l i f i c a t i on to e n s ure G MP e q u i p m e n t i s c o n t i n u o u s l y m a i nt a i n e d i n a v a l i d a t ed s t at e .



  • P r o g r a m, or g a n i z e, a nd m a i n t a i n V a l i d a t i o n e q u i p me nt a n d su p p l i es i n c l u d i ng d at a l o g g ers a nd p r o b e s .



  • Dem o n s trate a g e n e r a l u n d er s ta n d i ng of b i o p h ar m a c e ut i c a l m a n u factur i ng e q u i p m e nt a nd v a l i d at i on p r o c e d ures fo r I n s ta l l a t i on V eri f i c a t i on ( I V /IQ ) , Clean-In-Place (CIP), S t e a m- I n - P l a c e (S I P ) , A ut o cl a v e s , C l e a n U t i l i t i e s , S h i p p i ng V a l i d a t i o n, T e m p e r at u r e M a p p i n g C o ntro l l e d S tor a Client R o o ms a n d E q u i p m e n t.



  • De v e l o p va l i d at i on proto c o l s from p l a n s a nd e n g i n e e ri ng d o c u m e nts.



  • P r o v i d e b a s i c t e c h n i c al s u p p o r t w h en re v i ew i ng a n d a p pro v i ng S O P s , P r ot o c o l s , C h a n g e C o ntro l s , Dev i a t i o n s , C AP A , e tc.



  • P erfo r m as s i g n ed Q u a l i ty Sys te m s act i v i t i es w i t h i n D o c u m e n t M a n a g e m e nt S ys tem (D M S ) , T r a ck W i s e Qu a l i ty S ys tem ( C h a n Client C o ntr o l , De v i a t i o n , C A P A )

  • Perform other duties as assigned.


Job Sumary:
Equipment Validation Analyst
Shift: []
Start: []

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About LanceSoft

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Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

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