Scientist I, Microbiologist

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Division/Site Specific Information:

High Point, NC is a commercial manufacturing and development site focusing on gelatin based drug delivery dosage forms (softgels) . High Point is a Softgel Center of Excellence since 1996, offering extensive development and commercial scale capabilities for a variety of softgel technologies.

Location: 4125 Premier Drive, High Point, NC 27265

Discover Impactful Work:

T he QC Microbiologist-I i s r es po n si b l e f or t h e c o m p l e t e te s t i ng a nd re s u l t s d o c u m e n t a ti o n of a ny of t h e f o l l o w i n g : R a w Ma t e r i a ls , I n - P r o cess , F i n is h e d P r odu c t , S t a b i l i t y , T e c hn i c a l S er v ic e sa m p le s o r p r o je c t s w i t h i n t he Q C M i c r o b i o l o g y L a bo rat o r y , i n a m a nn e r c o n s i s t e n t w it h e s t a b l is h e d s ta n d ar d s .

Day in the Life:

T est i ng / D o c u me n t a ti o n : 80%

• Perform microbiological testing including identification of micro-organisms, water activity, bioburden, and growth promotion testing.
• Ensure all microbiological procedures reflect current practice and complies with current USP/EP requirements.
• Perform the routine Environmental Monitoring program on site.
• Co l le c t plant purified water and perform nitrate, chlorine, pH, TOC, and conductivity, and microbial testing.
• P re p a r e m e d ia , a nd/or us e t he commercially p re p a r e m e d ia for microbial testing , and au t o c la v e f o r w a s t e d is p o sal .
• Perform any microbial alert/action required from routine EM, water, microbial testing, etc.
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts, reporting metrics, and communicating internally to diverse audiences.
• Perform other duties as assigned.

S t and a r d i za ti o n s / P r e pa r a t o r y S e t U p: 10%

• P erf o r m daily verifications o f i n s tr u m e nts s u c h a s b a la n c es , pH m eter s, and pipettor a s r e q u ire d by wo r k i n str u c ti o n s .

• a m ong o t h e r s o l u ti o ns i n c l u d i ng m icr ob i o l o g ic a l s o l u ti o n s .

• P re p a r e m e d ia , and other microbiological solutions, us e t he A u t o c la v e f o r w a s t e d is p o sal .

• Order and receive lab supplies and maintain inventory of lab supplies.

H ou s e k ee p i ng: 5%

• C lean and or g ani z e a l l la bo rat o ry a r eas i n cl u ding b e n c h, s in k s, d r a w e r s, c ab i ne t s, sol v ent cabi n e t s, fu m e hoo d s, r e f ri g erato r s, f ree ze rs, d es i cc a t o rs, a n d s t ora g e a re a s.
• O cca s ion a lly c l ean lab o r a t o ry pipe t t e s and ot h er g la s s w are.
• Mai n t a in lab o r a tory i n s tr u m ents di s po s ing of w a s tes, c l ea n ing them, and r epl a cing consu m able p a r ts a s r equ i r e d. Maintain 5’s cleaning/ visual management in the laboratory.

T r a i n i n g and D e v el o p m e nt: 5%

• P ar t i c i p a t e i n on g o i ng t r ai n i ng f or t he d e v el op m e nt of s k ill s a nd res p on s i b i l i t y w i t h a n e m ph asi s on te c hno l o gy .

• A ssi s t t r a i n i ng of o t h e r a n a l y st s i n ar e a s o f e x p e r t i se .

Keys to Success:

B ac h e l o r ’ s D e g re e from an accredited College/University i n C h e m istr y , Micr o b i o l o gy , B i o l o gy , B i o c h e m is t r y, Biotechnology, or rel a te d f ie l d. Microbiology degree strongly preferred

No prior experience required in microbiology laboratory

KNOWLEDGE, SKILLS, ABILITIES:

• Must demonstrate a high level of commitment to delivering timelines and milestones to achieve business objective.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Excellent communication and listening skills
• Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
• Must comply with PSG Controlled Substance Policy and meet applicable DEA security clearance requirements if requested.

Excellent Benefits

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided

• Must be legally authorized to work in the United States now and in the future, without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening