Manufacturing Specialist CAPS

MedStar Health; Phoenix (AZ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading healthcare company in Phoenix seeks a Manufacturing Specialist to ensure compliance and quality in production processes. This role involves product inspections, managing documentation, and ensuring adherence to regulations in a cleanroom environment. Candidates should have relevant experience and strong attention to detail for this important position.

Benefits

401(k) plan

Tuition reimbursement

Healthcare benefits

Qualifications

• High school diploma/G.E.D or equivalent required.
• 4-6 years related experience required.
• Ability to work non-standard schedule as needed.

Responsibilities

• Perform product inspection for defects and leaks.
• Perform environmental monitoring of personnel and complete documentation.
• Assist in the media fill process validations.

Skills

Organizational skills

Attention to detail

Troubleshooting

Education

High school diploma/G.E.D

Associate's degree or technical degree preferred

Job description

Job Description

You're an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Manufacturing Specialist CAPS

Company:

Central Admixture Pharmacy

Job Posting Location:

Phoenix, Arizona, United States

Functional Area:

Production

Working Model:

Onsite

Days of Work:

Friday, Thursday, Wednesday, Tuesday, Monday

Shift:

5X8

Relocation Available:

No

Requisition ID:

5906

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:M-F 8AM-4:30PM

Responsibilities: Essential Duties

• Performs and writes investigations on manufacturing deviations and non-conformances.


• Responsible for preparation and updating controlled documents as needed.


• Works with site leadership to improve processes to reduce future non-conformances.


• Opens Change Controls in Trackwise and drives tasks to completion.


• Evaluate potential corrective actions for non-conformances and assist in implementation.
  
  

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons."

Expertise: Knowledge & Skills

• Requires working knowledge of technical field/area of specialization. Exercises general application of principles, theories and concepts. Follows established procedures and guidelines.


• Works under general supervision. May periodically assist in orienting, training, assigning and/or reviewing the work of other peers.


• May require some limited judgement in resolving problems


• Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• 
  

  High school diploma/G.E.D or equivalent required, Associate's or technical degree preferred.

  
  


• 04-06 years related experience required


• Ability to work non-standard schedule as needed

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 20 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:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally: Reaching upward and downward, Push/pull, Visual Acuity with or without corrective lenses


• Frequently: Stand, Sit


• Constantly:N/A

Activities:

• Occasionally: Handling, Push/pull, Reaching upward and downward


• Frequently: Sitting , Standing, Talking - ordinary, loud/quick


• Constantly:N/A

Environmental Conditions:

• Occasionally: N/A


• Frequently:Proximity to moving parts


• Constantly:N/A

Work Environment:

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.

• Noise Intensity:Moderate


• Occasionally:N/A


• Frequently: Office environment, Production/manufacturing environment


• Constantly:N/A

Target Based Range

$25.98 - 31.17

Position Summary:Monday-Friday, Second Shift 3:30pm-12am, holiday/overtime as needed

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

$25.98 - $31.17

#LI

#IND123

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.

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