Manager/Senior Manager, QA Analytical

Job Summary:

Manage the QA Analytical function at the KBI Biopharma, Hamlin location, supporting analytical laboratory operations in a contract biopharmaceutical manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with AFS, QC and Microbiology laboratories to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Cultivates and maintains Quality Assurance staff by recruiting, training, and managing QA team members. Align QA Analytical organization to meet company’s strategic goals. Experience managing a QA organization in both clinical and commercial operations is beneficial

Job Responsibilities:

• Leads and directs the QA Analytical team supporting analytical testing operations.
• Lead, assess, coach and develop departmental specialists. Manage performance, ensure team meets expectations and objectives. Guide the professional growth of team members by providing personal guidance and training relative to responsibilities
• Support GMP testing activities including release and stability testing. Oversees QA review of method qualifications, transfer, and validations. Oversees QA review of deviations, lab investigations, SOPs and GMP technical documents.
• Works directly with AFS and Microbiology to resolve deviations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing.
• Attend relevant operational meetings in support of issue resolution and escalation and batch disposition activities. Support client audits and regulatory inspections as required.

Job Requirements:

Knowledge, Skills, Abilities

• BS in scientific field with 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent. Experience in a in a QA role supporting GMP analytical testing is required. Minimum of 2 years of supervisory experience.
• Strong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs and knowledge of US, EU and Row cGMP guidelines.
• Experience with electronic laboratory information management systems is preferred.

Language

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

• Basic math skills are required. Ability to apply concepts of basic algebra and statistics.

Physical Demands

• Support manufacturing and warehouse operations to include movement and/or lifting of raw materials and consumables.

Computer Skills

• Knowledge of and experience using word processing, databases, spreadsheets, Power Point, Internet, E-mail, Calendar Management

Equipment

• Knowledge of and experience using a computer, a telephone

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.