QA Engineer-CAPS at Central Admixture Pharmacy

Company: Central Admixture Pharmacy
Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States, Phoenix, Arizona, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Wednesday, Thursday, Tuesday, Friday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 4059

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

CAPS®, part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.

Position Summary:

The QA Engineer will be supporting CAPS Pharmacy. This position supports the implementation and oversight of quality systems for compounded sterile preparations, ensuring adherence to regulatory standards and internal quality requirements. The QA Engineer applies knowledge of validation protocols, deviation analysis, and supplier quality assurance to mitigate risk and sustain manufacturing and product quality compliance.

Responsibilities: Essential Duties

• Reviews and helps establish quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
• Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.
• Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.
• Applies statistical methodologies for determination of acceptance of validations
• Conducts root cause analysis for defects, non-conformities or other quality failures.

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 advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
• Judgement is required in resolving complex problems based on experience.
• Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.

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.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required or equivalent combination of education and experience, Master's degree preferred.
• 02-04 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, Valid driver's license and passport
• cGMP training/experience required.

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, Stand
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:N/A
• Frequently:N/A
• 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:Other
• Frequently:N/A
• Constantly:Office environment

Salary Range:$73,987 - $92,489

Schedule is (8am-5pm) Monday-Friday

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: 73987-92489 Yearly Salary

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