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Quality Control Specialist
2 months ago
Summary: Conducts thorough inspection activities to ensure products meet established specifications. Oversees processes, supports operations, and upholds quality standards, policies, and procedures.
Key Responsibilities:
- Conducts and records a variety of inspections, tests, and sampling procedures from the point of receipt to packaging and distribution.
- Assists the QA/QC Director in managing quality assurance activities and training initiatives.
- Monitors production processes to ensure compliance with current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
- Performs line clearance to eliminate all previous products, components, and foreign materials.
- Executes first article and in-process inspections.
- Reports non-conformances to the Supervisor and suggests corrective measures.
- Reviews documentation for accuracy and completeness.
- Handles reconciliation and closure of batch records.
- Supports management in conducting inquiries and investigations.
- Ensures prompt release of finished products.
- Maintains quality records, reports, logs, and retention samples.
- Coordinates the disposal of expired records, documents, and products.
- Assists in preparing for customer and regulatory audits.
- Performs additional duties as assigned by management.
Qualifications:
- 2-3 years of relevant experience is required.
- Experience in the Dietary Supplement or Pharmaceutical sectors is preferred.
- Familiarity with cGMP regulations.
- Proficient in Microsoft Word, Excel, and Outlook.
- Strong verbal and written communication skills.
- Excellent interpersonal abilities.
- Capable of working independently and collaboratively.
- Ability to follow detailed instructions.
- Consistent attendance and punctuality.
- Willingness to work overtime as needed.
- Strong organizational skills and attention to detail, with the ability to thrive in a fast-paced environment.
Education:
- High School Diploma or equivalent is required.
- ASQ Certified Quality Auditor (CQA) and/or Certified HACCP Auditor (CHA) certification is preferred.
Work Environment:
The characteristics of the work environment are representative of those an employee may encounter while performing essential job functions. Reasonable accommodations may be made for individuals with disabilities.
While performing job duties, employees may be exposed to moving mechanical parts, fumes, airborne particles, and electrical hazards. The noise level is typically moderate, and personal protective equipment is required in the plant.
Physical Requirements:
The physical demands described are representative of those required to successfully perform essential job functions. Reasonable accommodations may be made for individuals with disabilities.
Physical demands include prolonged sitting and walking, bending, reaching, carrying, and occasionally lifting/moving objects up to 25 pounds. Specific vision abilities required include close vision, peripheral vision, and the ability to adjust focus. Employees must use hands for various tasks, reach with hands and arms, and may need to climb, balance, stoop, kneel, crouch, or crawl.