Quality Technician
3.
1 Easton, MD Easton, MD Full-time Full-time $16 - $18 an hour $16 - $18 an hour 12 days ago 12 days ago 12 days ago 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.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
1 Easton, MD Easton, MD Full-time Full-time $16 - $18 an hour $16 - $18 an hour 12 days ago 12 days ago 12 days ago 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.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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