Available Openings 1
PURPOSE AND SCOPE:
Inspects incoming materials for specific characteristics and specifications set forth by quality procedures. Responsible for daily spot-checking process controls, various label control activities, preparation of product samples for internal laboratory analysis, and shipment to testing facilities. May be assigned to review quality/production records for accuracy, completeness, and conformance to all applicable procedures.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Under close supervision, prepares, performs, and controls raw material/packaging material incoming inspections and Material Inspection Reports.
- Verifies and records the receipt of components and their condition upon arrival. Documents condition of nonconforming components (description, photographs, etc.) for Material Review Board (MRB) disposition.
- Assigns lot control identification to all incoming production components (chemical components, packaging components, etc.).
- Samples and inspects packaging and chemical components according to approved procedures to ensure conformance with specifications.
- Performs inspections/audits of the process to ensure conformance with SOP procedures and identification as needed.
- Prepares and issues all finished product labels in accordance with established label control procedures.
- Prepares samples for internal laboratory testing or for shipment to an appropriate testing facility
- Reconciles all finished product labels.
- Records, counts, interfaces with issuing facility, and maintains/adjusts the label inventory as necessary.
- Receives and inspects the incoming product labels.
- Maintains effective communication with vendors.
- Assists with validations as required.
- Cleans and maintains inspection work areas.
- May be required to assist with the testing of raw materials in the Chemistry Lab.
- May be assigned to assemble device history records (DHR) for issuance to production.
- May be assigned to review finished DHRs for completeness and correctness.
- May be responsible for DHR post production review and compiling of error metrics – Dry and Liquid.
- Works cross-functionally in other area of the QS unit.
- Conduct process audits to monitor the effectiveness of controls.
- Participates in continual improvement projects.
- Collects, analyzes, and reports performance data related to assigned responsibilities.
- Works on assignments that are routine in nature, requiring limited judgment.
- Contacts are primarily within immediate work unit.
- Normally receives detailed instructions on all work.
- May refer to higher level staff for assistance with day-to-day problems that may arise.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various projects as assigned by direct supervisor.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
May occasionally be required to lift and/or move up to 50 pounds.
High School Diploma required.
1 year of college or technical school preferred, or equivalent experience and training in quality systems/material inspections.
EXPERIENCE AND REQUIRED SKILLS:
- 0 – 1 year of related experience in a chemical, food, or drug manufacturing facility, or in a quality related role.
- General knowledge of GMP regulations and standard quality control inspection techniques.
- Must have good organizational skills, and ability to perform work in a team environment with a minimum level of supervision.
- Must be detail oriented and be capable of interpreting drawings/specifications.
- Must be capable of applying inspection/sampling plans/techniques to verify if materials/components conform to the applicable drawings/specifications.
- Must have an aptitude for math with basic algebraic skills and measurement skills.
- Ability to prepare routine administrative paperwork.
- Records maintenance skills.
- Knowledge of the structure, policies and procedures of FDA regulated facilities (21 CFR Part 820 Medical Devices).
- Skill in the use of personal computer and related software applications.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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