Top 2 Microbiology Jobs in Hastings Ne

Compliance Specialist 1
Nova-Tech Inc —Grand Island, NE
- From $22.93 an hour
- Full-time
- Background check
- Bachelor of Science
- Pass drug screening
- Health savings account
- Paid holidays
Quick Apply
8d

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Compliance Specialist 1

Nova-Tech Inc -
Grand Island, NE

Quick Apply

Job Details

Full-time
From $22.93 an hour
8 days ago

Benefits

Health savings account
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
401(k) matching
Flexible schedule
Referral program
Retirement plan

Qualifications

Coaching
Drug regulation
English
GMP
Bachelor's degree
Attention to detail
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Quality audits
Aseptic technique
FDA regulations
Time management
Pharmaceutical manufacturing facility experience

Full Job Description

Job Summary:

Part of Quality and Compliance oversight and function of a GMP sterile fill manufacturing operation. Passion and alignment with our mission, vision, values, and operating principles in order to achieve company initiatives, goals, and objectives.

Job Scope:

The Compliance Specialist is a part of the Quality Unit, which includes Quality Systems (QS) and Laboratory Control (LC). The Compliance Specialist will be a part of the Quality Unit has the oversight of manufacturing and ensures the products manufactured are according to FDA’s regulations and GMP to be pure, safe and effective. The Compliance Specialist will provide support for continuous improvements via system improvements, non-conformance investigations, and implementing Corrective/Preventive actions. The Compliance Specialist should possess proven technical writing and problem-solving skills as well as a desire to develop investigators in the art of problem-solving analysis.

Responsibilities:

Oversight of the Manufacturing Operations’ and Laboratory Controls’ deviation, OOS, complaint investigation, change management, and ensure non-conformance investigations meet or exceed the internal, customer and regulatory reviewer’s expectations.
Routinely analyze investigations and CAPA performance to Management team for transparency and drive accountability for non-conformance closure and escalation of adverse trends.
Tracking and trending of Quality Metrics
Conduct Risk Assessments for topics such as new product introduction, quality systems evaluations, equipment selection.
Participate in training on i.e. consequences and outcomes of deviations and investigations.
Participate in FDA, internal, and customer audits.
Participate in preparation, documentation, and submissions to regulatory agencies.
Participate in providing responses to regulatory agencies regarding product information or issues.
Perform Annual Product reviews
Other duties as assigned

Job Skills/Knowledge:

Must have an understanding of FDA regulation and pertinent state and federal laws governing pharmaceutical products, manufacturing, and marketing.
Desire to own decisions and take responsibility.
Must have excellent organizational, communication, and coaching skills.
Ability to gown in an aseptic manufacturing environment.
Exceptional attendance

Education/Experience

BA/BS Degree in a science field preferred (i.e., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience
Three years prior experience in Quality Assurance in Pharmaceutical Discipline
Experience in quality management systems
Experience in quality system audits
Proficient in Microsoft Office
Ability to read, write, speak, and understand English sufficiently to perform the duties of this position

Pre-Employment Screening:

Drug Screening including use of tobacco
Background Screening
Visual Acuity Screening

Benefits Summary:

Paid Vacation
Holiday, Sick, and Birthday Pay
Group Insurance Plan including Health, Dental, Vision, Voluntary Life, Short Term Disability, Critical Illness, and Accident Expense
Flex Savings Plan
Safe Harbor 401(k) Plan
Direct Deposit
Paid Uniforms, including Safety Shoes

Job Type: Full-time

Pay: From $22.93 per hour

Benefits:

401(k)
401(k) matching
Dental insurance
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Paid time off
Referral program
Retirement plan
Vision insurance

Application Question(s):

Are you a tobacco/nicotine user?

Ability to Relocate:

Grand Island, NE 68801: Relocate before starting work (Required)

Work Location: In person

Quick Apply

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