Principal QA Specialist

KBI Biopharma, Inc.; North Carolina; Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

KBI Biopharma, Inc. is seeking a Principal QA Specialist in North Carolina to lead compliance review of GMP data, oversee QA activities across analytical and microbial labs, and support product lifecycle and regulatory inspections.

The role emphasizes patient safety, regulatory adherence, and cross-functional collaboration. The position requires deep QA/QC and cGMP expertise, with extensive experience in FDA/EU regulations, method qualification, and CAPA processes.

Qualifikationen

• Bachelor’s degree and 10+ years' experience or Master’s degree and 6+ years' experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Strong understanding of FDA, EU and cGMP regulations is required.
• Experience in Quality Control and Quality Systems is beneficial.

Aufgaben

• Performs timely review of test data for in process, release, and stability samples.
• Assures activities comply with required procedures, cGLP, and cGMP requirements.
• Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing.
• Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs.
• Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities.
• Supports client audits and regulatory inspections as required.
• Other activities as assigned by Management.
• Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals.
• Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

Kenntnisse

QA oversight

cGMP knowledge

Regulatory understanding

Interpersonal skills

Team collaboration

Problem solving

Attention to detail

Quality culture

Ausbildung

Bachelor’s degree

Master’s degree

Tools

MS Office

LIMS

Databases

Jobbeschreibung

JOB SUMMARY

This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with clients, laboratories, manufacturing, QA batch disposition and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture. May perform as a team lead for a specific responsibility listed below, in which case, the Approximated amount of time will be skewed toward the specific responsibility

JOB RESPONSIBILITIES

• Performs timely review of test data for in process, release, and stability samples.
• Assures activities comply with required procedures, cGLP, and cGMP requirements.
• Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing.
• Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs.
• Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities.
• Supports client audits and regulatory inspections as required.
• Other activities as assigned by Management.
• Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals.
• Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

MINIMUM REQUIREMENTS

• Knowledge, Skills, Abilities Bachelor’s degree and 10+ years' experience or Master’s degree and 6+ years' experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills. Strong understanding of FDA, EU and cGMP regulations is required. Experience in Quality Control and Quality Systems is beneficial.
• Language Ability 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 Sitting for long periods of time working at a computer workstation. Pushing and pulling up to 30 pounds.
• Computer Skills Use Microsoft Office Word, Excel, PowerPoint, Outlook, and Teams, Database, Spreadsheets, Internet, and LIMS.

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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.

Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.