Quality Technician - Process Control

Stryker Corporation; Allentown (Lehigh County); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player in healthcare is seeking a detail-oriented Quality Compliance Associate to ensure adherence to quality standards in a cleanroom environment. This role involves conducting inspections, maintaining quality records, and supporting audits to enhance patient safety and operational efficiency. If you have a passion for quality assurance and are ready to contribute to a team dedicated to excellence, this opportunity is perfect for you. Join a company that values expertise and offers a collaborative work atmosphere where your skills can make a significant impact.

Benefits

Healthcare benefits

401(k) plan

Tuition reimbursement

Qualifications

• Minimum of 2 years experience in quality or manufacturing.
• Experience in aseptic operations is a plus.

Responsibilities

• Perform product inspections for defects and leaks.
• Assist in media fill process validations.
• Maintain quality records and support audits.

Skills

Knowledge of pharmacy operations

Ability to perform calculations

Strong organizational skills

Attention to detail

Troubleshooting issues

Education

High School Diploma/GED

Associates Degree in Biology/Microbiology/Chemistry/Pharmacy

Job description

Company: Central Admixture Pharmacy
Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 4029

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position Summary:

Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.

Essential Duties/Responsibilities:

• Perform product inspection for defects, leaks and particulates.
• Perform environmental monitoring of personnel (as needed) and complete documentation.
• Assist in the media fill process validations to include inspection of filled units
• Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:
  • Verify that raw materials meet specification
  • Verify and account for labeling
  • Review temperature and BMS alarms
  • Verify that product test results meet specification limits
  • Verify that all documentation is complete
  • Document non-compliance and work with supervisor/lead if further investigation is needed
• Submit samples to the appropriate lab for particulate identification or microbial analysis.
• Assist with equipment calibration program and maintenance record files.
• Assist with raw material release and movement.
• Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
• Support internal & external audits.
• Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
• Participate in Quality Manager's staff meetings

Expertise: Knowledge & Skills

• Knowledge of pharmacy operations and regulatory guidelines.
• Ability to perform calculations.
• Ability to work within established procedures and practices
• Strong organizational skills and attention to detail
• Ability to effectively troubleshoot issues.

Qualifications - Experience/Training/Education/Certification/Etc:

Required:

• Minimum of High School Diploma/GED with work experience
• Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.

Desired:

• Experienced in aseptic operations.
• Experience within a regulated environment
• Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds.

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

• The employee must occasionally lift and/or move up to 45 pounds.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Target Based Range

$17.21-$21.52

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Compensation details: 17.21-21.52 Hourly Wage

PIec276125f674-35350-37367482

Company: Central Admixture Pharmacy
Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 4029

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position Summary:

Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.

Essential Duties/Responsibilities:

• Perform product inspection for defects, leaks and particulates.
• Perform environmental monitoring of personnel (as needed) and complete documentation.
• Assist in the media fill process validations to include inspection of filled units
• Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:
  • Verify that raw materials meet specification
  • Verify and account for labeling
  • Review temperature and BMS alarms
  • Verify that product test results meet specification limits
  • Verify that all documentation is complete
  • Document non-compliance and work with supervisor/lead if further investigation is needed
• Submit samples to the appropriate lab for particulate identification or microbial analysis.
• Assist with equipment calibration program and maintenance record files.
• Assist with raw material release and movement.
• Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
• Support internal & external audits.
• Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
• Participate in Quality Manager's staff meetings

Expertise: Knowledge & Skills

• Knowledge of pharmacy operations and regulatory guidelines.
• Ability to perform calculations.
• Ability to work within established procedures and practices
• Strong organizational skills and attention to detail
• Ability to effectively troubleshoot issues.

Qualifications - Experience/Training/Education/Certification/Etc:

Required:

• Minimum of High School Diploma/GED with work experience
• Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.

Desired:

• Experienced in aseptic operations.
• Experience within a regulated environment
• Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds.

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

• The employee must occasionally lift and/or move up to 45 pounds.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Target Based Range

$17.21-$21.52

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PIec276125f674-35350-37367482