The schedule for this position is 7p - 7a on the D shift.
Audits and reviews product/processes at various stages of manufacture to ensure compliance with cGMP standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Performs real time quality audits and batch record reviews throughout the designated shift. This includes auditing each encapsulation room and dispensing area, post production printing/packaging rooms, gelatin area and medicine rooms during the manufacturing process to ensure quality of the product in process. Items audited during this process include, but are not limited to, the cleanliness of the rooms and equipment, the segregation of product, medicine and gel lot numbers on line, mixing requirements during the run, documentation and overall cGMP compliance issues.
- Participates in the internal audit program by performing audits of specific areas as directed by the Sr. QA Auditor. Performs routine audits and logbooks used in the operations area for completeness and cGMP compliance.
- Performs finished product quality assurance sampling/inspection. Samples are pulled at the beginning, middle, and end of a run. Specific checks are listed on the Acceptance Quality Level checklists. Submits documentation to Batch Release for review.
- Pulls retain samples for each lot produced, which are then stored in the Retain Cage of the warehouse. Pulls and submits retained samples from finished product as requested
- Performs sample evaluations on bottled products from contract packagers and submits evaluations and BPRs to Batch Release for review.
- Performs non-routine sampling and testing of products/materials as applicable. This includes random sampling as per customer request. Performs pre-shipment checks as requested by Batch Release or QA Management.
- Verifies information on labels and places secure tags on labels. Issues labels to production (packaging) prior to packaging the product. Prints bulk labels to be used in the Post Production department, as needed.
- Initiates Trackwise events and complete appropriate forms, as required.
- Serves as back up for the Bulk Label Printing area.
- May perform other reasonable, related business duties.
- Serves as a resource to the operations areas on quality related issues.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
High School Diploma, GED or equivalent and 6 months of GMP experience required OR a 4-year degree and no experience.
Ability to effectively present information in one-on-one and small group situations to employees of the organization. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports. Ability to effectively present information and respond to questions from associates, leads and supervisors.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to deal with problems involving a few concrete variables in standardized situation.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
OTHER SKILLS AND ABILITIES:
Ability to use a PC and the following software: Microsoft Office suite, Lotus Notes, SAP and Windows based applications. Needs to be able to multi-task. Trackwise experience is a plus. Ability to understand FDA cGMP requirements in the pharmaceutical and nutritional industries.
CERTIFICATES, LICENSES, REGISTRATIONS
Must meet applicable DEA security clearance requirements.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. While performing the essential duties of this job, the employee is occasionally required to talk/hear/listen (communicate with others). The employee is frequently required to bend or stoop. The employee is regularly required to stand continuously, walk, reach with hands and arms, and use hands to finger, feel, or handle. The employee must occasionally push/pull/lift/carry up to 50 pounds and regularly up to 10 pounds. Close vision, color vision, peripheral vision, and depth perception are required.
The employee may be exposed to wet or humid conditions, work near moving mechanical parts, fumes or airborne particles and toxic or caustic materials. The noise level moderate to loud.
PERSONAL PROTECTIVE EQUIPMENT
Uniform (or lab coat), gloves, safety glasses, safety shoes, hair protection, and earplugs. Certain jobs also require the use of a hood due to the chemicals that are involved.