Quality Specialist I - QOTF
Quality Specialist I - QOTF
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
12 hr shift/daysEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc. Standing for full shiftJob Description
Summary:
Assists in the investigation and monitors Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices company SOPs and product registrations are followed and maintained. Assists in the investigations of batches preps lots equipment and facilities as required per the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA requirements. This role will support CPI Granulation and Dispensing.
Shift:
Monday Wednesday 6:00am 6:30pm
Essential Functions:
- Acts as a resource to operations teams and problemsolving groups and aids in resolution of problems.
- Assists Operations and Quality Operations in implementing corrective action for process deviations assisting with CAPA initiatives.
- Conducts GMP inspections of facilities to assure compliance with the current GMP regulations.
- Performs housekeeping inspections to assure Operations is maintaining work areas in an orderly and clean manner.
- Assures that operators are following written instructions and methods and procedures via realtime record review.
Education:
- High School Diploma/GED Required
- Bachelors Degree in Science or applicable field preferred
Experience:
- 3 years of QA experience required
- 2 year experience Manufacturing. Process Engineering Engineering services and/or GMP environment preferred
Competencies:
- Through knowledge of OSD manufacturing including equipment and process understanding.
- Excellent problem solving and writing skills.
- Ability to work on multiple projects simultaneously adaptable for a fastpaced fluid environment.
- Strong attention to detail
- Works well independently and leads collaboratively within team and crossfunctionally.
Required:
Requires a basic understanding of the practices principles and theory of GMP Services
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand walk stoop kneel crouch periodically for prolonged periods of time; manipulation (lift carry move) of light to medium weights of 1035 pound pounds; arm hand and finger dexterity including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time; ability to sit reach with hands and arms talk and hear for prolonged periods of time.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
