Quality Technician - Easton, United States - Aphena Pharma Solutions
Description
Aphena Pharma Solutions is looking for
_Experienced Quality Tech on Day Shift__ _**to join our team in Easton, Maryland We are a dynamic pharma solutions provider focused on contract packaging, repackaging and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health and medical device marketplaces.
BENEFITS INCLUDE:
Employee Medical Premiums Paid at 75% by Aphena
Company Pays Portion of Medical Deductible
Company Paid Short Term Disability & Life Insurance
401k Match
PTO Awarded After 30 Days
Paid Holidays & MORE
Job Tasks
- Inspect incoming components, inprocess product, and finished product according to documented specifications.
- Review all documents prior to the start of production and complete first piece approval (FPA) as required.
- Record data and maintain accurate records in accordance with GMP good documentation practices
- Prepare inspection sheets and other needed forms using Microsoft Word or Microsoft Excel.
- Troubleshoot quality concerns that may arise on the production floor
- Review all paperwork, including device/drug history records (DHR), daily for accuracy and completeness
- Verify the calibration of all inspection test equipment and maintain accurate records.
- Gather data and investigate relative to customer complaints.
- Participate in the execution and documentation of process validations.
- Assist in maintaining the quality management system to be in compliance with the current ISO standard and applicable FDA GMP Regulations.
- Perform data entry and retrieval using the Aphena computer system.
- May be required, as needed, to work overtime, weekends or alternate shifts.
- Perform preapproval inspections and maintain accurate records.
- Assist in the generation and resolution of corrective and preventive action plans (CAPAs.)
- Assist in the documentation and resolution of nonconforming material reports and process discrepancy reports.
- Generate controlled labels as needed using programs provided. Document same using proper approval forms and paperwork to issue and return materials from the Label Control Area.
- If necessary, initiate nonconforming or process discrepancy documentation including data entry and labeling requirements. Also responsible for stock segregation if necessary.
- Assist in material flows required to maintain label control operations including consolidation, relocation, and other practices.
- Maintain work area orderliness and cleanliness.
_ Must be willing to work Monday through Thursday, 4 x 10-hour shifts from 7:00A-5:30P with possible mandatory overtime on Friday as needed from 3:30P-12:00A
_:
- Normal work week is 40 hours per week.
Job Skills
(REQUIRED)
- PC proficient (knowledge of Microsoft Word and Microsoft Excel)
- Knowledge of FDA Good Manufacturing Practice (GMP) Regulations pertaining to medical devices and pharmaceuticals.
- Knowledge of the International Organization for Standardization (ISO) standard.
- Ability to prioritize assignments.
- Good communication skills
- Good writing skills
- Ability to interact with customers and/or vendors on an as needed basis.
- Ability to read and understand drawings and templates.
- Manage multiple projects in a time sensitive environment.
- Complete projects on time.
- Proven analytical, problem solving and troubleshooting skills.
- Ability to interact with all levels within the organization.
- Ability to train all levels within the organization.
(PREFERRED)
- Knowledge of Statistical Process Control (SPC) systems.
- Ability to flowchart and graph data.
Personal Attributes
- Dependable
- Detail oriented
- Flexible
- Energetic
- Self starter
- Trustworthy
- Works well with others
- Works well under pressure
- Good personal hygiene
- Good communication skills
- Ability to prioritize tasks
- Ability to make decisions
Physical Requirements
- Receive instructions through oral communications accurately and quickly.
- Convey answers or instructions to other workers accurately, loudly, and quickly.
- Must be able to lift and move materials up to a maximum of 50 pounds.
- Will be exposed to inside and outside environmental conditions.
- The physical activity of this position includes, but is not limited to: Climbing, Walking, Stooping, Kneeling, Crouching, Reaching, Standing, Pushing, Pulling, Lifting, Grasping, Twisting, Sitting, and Feeling.
- The inspector should have good visual awareness.
Education/Experience
Education
- High school graduate required.
- Advanced college level courses, preferred.
Experience
- Previous experience working with GMP Regulations pertaining to medical devices or pharmaceuticals.
- Superior written and verbal communication skills required to communicate issues and procedures among multiple departments.
- Competent with Microsoft Excel, Word and the Internet.
- Ability to solve complex, multilayered problems.
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