Responsible for Quality Control functions including, conducting physical testing of raw materials, assisting in Document Control of Quality Control Documents and assisting with all Quality Unit needs as they pertain to quality system compliance.
Reporting Relationships: Individual Contributor
- Perform basic QC testing of raw materials and packaging components.
- Create, collect, track/trend, and maintain testing data in the appropriate document.
- Prepare samples for shipment.
- Maintain laboratory inventories.
- Prepare, review and revise laboratory SOPs as required.
- Identify raw materials, bulk and finished product disposition with appropriate labeling.
- Write and revise specifications; maintain QC files, methods and other laboratory documents as needed.
- Perform data trending activities as assigned.
- Scan, copy, and file laboratory documents for customers or Regulatory Affairs as needed.
- Collect and prepare laboratory samples for shipping.
- Keep Manager informed of all key quality findings and issues.
- Assume other activities and responsibilities from time to time as directed.
- BS in Microbiology or related field and 1-2 years experience highly preferred.
- Demonstrated ability to work on multiple projects and meet timelines
- Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- Excellent organizational skills. Demonstrated ability to work on multiple projects and meet timelines. Detail oriented
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Proficient written and oral communication skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.