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, in-process 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 pre-approval 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 non-conforming 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.
• The schedule for the shift and workstation maybe subject to change.
• Normal work week is 40 hours per week.

Qualifications

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 trouble-shooting 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 subject to dust, perfumes, and chemicals.
• 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, multi-layered problems.