Quality Assurance (QA) Process Control Lead
Location:
Allentown, PA
Posted:
November 16, 2016
Position Type:
Full Time
Category:
Quality Assurance
Reference:
2016-8947
Overview: Central Admixture Pharmacy Services, Inc. (CAPS®) is the nation's largest network of outsourcing admixture pharmacies. CAPS, a pioneer in the outsourcing of compounded sterile preparations was founded in 1991.

State-licensed and FDA-registered, CAPS pharmacies deliver solutions from more locations than any other national compounder. CAPS provides both custom and standard solutions to hospital and outpatient providers from our 25 locations across the United States. Making over 300,000 local deliveries annually, CAPS pharmacies operate 365 days a year to dispense labeled, patient-specific and anticipatory IV prescriptions to our health system pharmacy customers.

CAPS believes safety is job one. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry. We perform environmental monitoring, regular process validations, and daily process sterility testing as part of our routine Continuous Quality Assessment and Improvement Program.

The CAPS service is focused on the daily admixing, dispensing, and delivery of a variety of CSPs. CAPS uniquely trained and licensed pharmacy personnel compound a broad range of patient and non-patient specific CSPs embracing the latest compounding technology, including proprietary software for ordering prescriptions and barcode safety checks for automated and manual compounding processes.

Each CAPS pharmacy is managed by a pharmacist with well-established compounding expertise. These directors manage a team of licensed pharmacists and certified technicians trained on CAPS Standard Operating Procedures. CAPS employs a QA team of chemists, microbiologists, and on-site quality assurance personnel who are accountable independently from the admixture staff. Quality Assurance reports are provided to our clients on a quarterly basis.

Orders are sent via CAPSLink, a web-based proprietary ordering software that can manage both complex and patient-specific prescriptions like Parenteral Nutrition (PN) and anticipatory compounded (AC) non-patient-specific order requests. CAPS ordering system can also interface with your pharmacy management software for convenience and broader custom service options. Pharmacists review orders upon receipt and prepare your order using an automated compounding process and a bar coded manual-add-system (MAS) to verify ingredient accuracy.

CAPS mixes to order so you can be assured your order is freshly compounded and has maximum beyond use dating (BUD) when delivered. CAPS has a variety of delivery options including same day and next day services.

Responsibilities: Position Summary:
This position requires a hands-on high-level expertise in quality assurance for compounding processes. The QA Process Control Lead will be responsible for supervising routine work, providing direction, and training to Quality Control Coordinators (QCC). Responsible for performing in-process inspection and process monitoring, batch record review and release activities, label control and quality investigations/resolution, process verifications to ensure compliance with operating procedures and specifications.
Responsibilities: Essential Duties
  • Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments.
  • Lead root cause analysis and corrective and preventive actions for audit observations, product complaints, product non-conformances, in-process deviations, CAPA, and SCAN issues related to process controls.
  • Direct the investigation of excursions in Manufacturing or other related operations. Resolves nature of the cause, impact on product quality, disposition and corrective actions.
  • Supervise routine work, provide direction, and training to QCCs.
  • Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
  • Performs final review of test data/reports to ensure conformance to the established specifications and standard operating procedures.
  • Writes collects, organizes and compiles data and reports to provide information for use by management or to comply with goals and regulatory requirements.
  • Prepare/revise operating procedures and specifications.
  • Review/approve routine change control requests as designated.
  • Perform compounding process verifications to ensure compliance with operating procedures and specifications (for example, verify proper line clearance, compliance with operating and inspection procedures, operation of equipment per validated parameters, equipment calibrated, operators trained, compliance with gowning and clean room procedures, etc.)
  • Responsible for responding to clean room alarms to verify compliance with excursion requirements. Assess status and determine the appropriate actions needed to be taken.
  • Control of product labeling/Label accountability.
  • Review of batch records including control check sheets, notebooks, raw data, reports, certificates of analysis, etc. to ensure completeness, accuracy and conformance with specifications.
  • Provide support for quality investigations and resolution of quality issues.
  • Compile, report and interpret quality trend information.
  • Perform all activities with a working knowledge of Company procedures and specifications and government regulations that govern the process.
  • Review data and assign disposition to test results including but not limited to environmental data, in-process audit results.
  • Maintain current knowledge of regulatory and industry standards, trends and advancement.
  • Conduct routine and non-routine audit and analysis of in-process activities according to established procedures.
  • Maintain accurate, complete records and ensure documentation is consistent with written procedures.
  • Prepare and revise procedures to comply with cGMP requirements based on current processes and observation results from in process audits.
  • Work independently and effectively with various quality functions to assure conformance to FDA regulatory requirements and internal processes and policies.
  • Work effectively across different business units.
  • Uses computerized systems needed for product release and control, document control and quality investigation processes.
  • Prioritize tasks in a high pressure and deadline driven environment.
  • Oversee process controls to ensure product quality and all specifications are met. Ensure products are released on time and within specification.
Expertise: Knowledge & Skills
  • Good working knowledge of Pharmaceutical (USP , 21 CFR 210 & 211, and 503B)
  • Good working knowledge of USP, FDA/cGMP, ISO, and ICH requirements
  • Effective communication skills, both written and verbal.
  • Leadership skills and the ability to facilitate the work activities of others
  • Ability to act effectively as a member of a team to resolve problems.
  • Ability to analyze and troubleshoot
  • Advanced and specialized expertise, typically developed through a combination of job-related training and considerable on-the-job experience.
  • Good organizational and time management skills
  • Good computer skills
  • Ability to complete assignments timely


Qualifications: Expertise: Qualifications - Experience/Training/Education/Etc
Required:
  • BS degree in technical or scientific discipline and five or more years of related experience preferably in the pharmaceutical and or medical device industry.
  • Ability to work autonomously within established procedures and practices.
  • Experience with USP, cGMP's, and FDA guidelines.
  • Valid driver license required
  • May be required to travel approximately 20% per calendar year
Desired:
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.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other: 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 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:
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.
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