Group Leader QA/QC / 475

Position Description:We are currently seeking a QA/QC Group LeaderTo qualify for this position, candidates must possess/or meet the following requirementsQUALIFICATIONS GUIDELINES: Bachelor’s degree in Microbiology or related science. Current experience and working knowledge of steam sterilization process. Familiarity with cGMP and FDA Guidelines. Five plus (5+) years Quality Control laboratory experience in a pharmaceutical and /or medical device company. Excellent organizational and communication skills.Desired: Three plus (3+) years supervisory experience, can be combined with laboratory experience.JOB PURPOSE:Responsible for supervising the Sterility, Media, Particulate Matter (PM), and Sterility Assurance group to ensure that the area operates efficiently and effectively in order to meet company goals, and maintain cGMP compliance.Specific Job Purpose:Supervise resources in order to meet departmental and company objectives. Take initial steps to address any aberration in the sterilization cycles. Ensure all QC Microbiology laboratory equipment is calibrated and validated per master schedule. Working experience in microbiology, terminal sterilization and cycle development, (steam/moist heat). Thorough understanding of biological indicator organism resistance testing (D and z value analysis). Aseptic fill processing experience is a plus.ESSENTIAL FUNCTIONS: * Responsible for staffing, training, and development of subordinates, and the control of financial resources where applicable.* Provide technical assistance and direction to other functional groups ensuring appropriate corrective actions are taken.* Interface with Sterilization and Manufacturing in resolution of certain sterilization issues as they arise.* Support Quality Systems to establish and maintain satisfactory levels of compliance with cGMPs, GLPs, and area procedures.* Support the internal audit program to determine and correct any deficiencies in the area of responsibility.* Participate in the investigation of excursions in Manufacturing/QC or other related operations resulting in Non-Conforming Lot Reports (NLR) and draft Investigation Reports (IR) as required. To include cause, impact to implicated materials, disposition, corrective and preventive actions.* Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.* Provides technical and supervisory guidance to Sterilization Assurance Associates and Manufacturing personnel in order to achieve satisfactory conclusion to “atypical� production runs or test results.* Reviews sterilization batch records to ensure conformance to acceptance specifications.* Reviews sterilization qualification and requalification packages.* Evaluates sterilization and PM data trends to ensure that the sterilization process and finished product PM levels are operating normally and that appropriate corrective actions are taken to correct deviations.* Responsible for ensuring the validation and revalidation of all microbiology laboratory equipment by assigning available resources.* Supports other areas of the Microbiology Department when required.SPECIFIC ESSENTIAL FUNCTIONS;* Organizes staff to accomplish goals efficiently and actively participates in the recruitment process of additional personnel as required.* Monitors progress of projects (if applicable), confers with project engineers, and reviews reports to see that project objective has been adequately addressed.* Monitors department expenses according to approved budget.* Monitors progress of projects (if applicable), confers with project engineers, and reviews reports to see that project objective has been adequately addressed.* Sets priorities with a proper sense of urgency and importance.* Attend to the needs of and maintain a high customer service level.SPECIFIC QUALIFICATIONS:* Knowledgeable enough to assess sterilization aberrations in the steam sterilization of applicable product and vessel qualifications.* Be self-directing.* Able to direct resources to achieve department goals.* Ability to develop a spirit of teamwork and cooperation.* Ability to communicate effectively with people at different functional levels.SPECIFIC BODY OF KNOWLEDGE:* Code of Federal Regulations CFR 21, Part 210 and 211 “cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals�* Code of Federal Regulations CFR 21, Part 820 “Quality System Regulation�* Familiarity with and ability to keep current in ANSI, AAMI, ISO, CEN, USP, and FDA standards and guidances* Ability to “navigate� through the general chapters in current US Phamacopeia (USP) relating to Microbiological and Biological tests and assays* Familiarity with statistical applications and softwareSKILLS/ABILITIES:* Sufficient human relations skills to effectively staff and supervise relevant personnel and functions to assure that company goals and responsibilities are met* Excellent written and verbal English skills* Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company* Proficient in the use of computers including Microsoft Office SuiteB.Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension, 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 An EOEThrough its “Sharing Expertise®� initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.