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Quality Specialist I
2 months ago
Weekend days
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), No eye contacts allowed; prescriptive glasses will be provided, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.)
Job Description
Quality Specialist I
Hours:Thursday-Friday-Saturday Day Shift 6:00am-6:30pm includes a 10% shift differential.
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.
Essential Functions:
- Acts as a resource to operations teams and problem-solving 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 real-time record review.
Education:
Minimum requirement High School Diploma, preferred Bachelors Degree in, Science or applicable field.
Experience:
Minimum of 2 years of accumulated experience in QA, Process Engineering, Engineering services or Manufacturing.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
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 fast-paced fluid environment.
Strong attention to detail
Works well independently and leads collaboratively within team and cross-functionally.
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 10-35 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 .
