QA Validation Specialist 3

Lancesoft

Portsmouth, NH

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JOB DETAILS

SALARY

$80

LOCATION

Portsmouth, NH

POSTED

8 days ago

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: []

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

QA Validation Specialist 3

Lancesoft

Portsmouth, NH

About the Company

Lancesoft

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