Sr. Specialist, QC Biochemistry

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 37 days ago

Duties & Responsibilities:

  • Responsible for both executing the tactical operations and overseeing junior team members executing testing. Under no supervision leads/participates in analytical laboratory investigations, solve technical problems such as invalid assays or equipment breakdown, and identify aberrant results to management. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner.
  • Must be able to pro-actively identify issues to prevent missed timelines.
  • Provides guidance to MFG, E&T, and/or QA to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QC and the business including the on-going training of junior team members. Must be able to interact effectively with other groups to provide support, review of data, sharing of information/scheduling.
  • Independently serves as QC representative in decision making and conflict resolution with junior team members as needed in the absence of the department head.
  • Identifies and resolves critical issues (including deviations, investigations, OOS, etc.), as appropriate and typically works on complex Major issues. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
  • Authorized to inhibit the release of test results when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue testing. Is required to resolve critical issues utilizing independent judgment and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the Sr. QC Specialist utilizing the input of others to make a final compliance determination.
  • Highly productive, attention to detail, ability to manage own time and time of junior staff to prioritize tasks independently and meet timelines. Maintain laboratory to a high quality and compliance standard. Provide supervisory role to ensure testing result is released on time in Manager's absence.
  • Responsible for method validation and method transfer activities. Must understand ICH guidelines and translate requirements into effective experimental designs. Must be able to manage completion of entire method validation including the coordination of approvals for protocols/report, completion of experiments by other junior analysts, incorporation of comments into protocols/report, and overall completion to agreed timelines and ensuring communication/escalation of potential issues of broader impact to the business. Actively support cross functional teams and share information, able to initiate and effectively conduct cross-functional meetings as appropriate, with colleagues.
  • Effectively communicate with supervisors, colleagues and/or managers in other departments and sites. Sought after by junior team members for guidance on method validation, transfer, qualification.
  • Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QC responsibilities. Ensures all specifications, assay and system suitability are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and approved are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments.
  • Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems. May be asked to become a certified Green-Belt and be assigned to lead process improvement initiatives via the BPE program. May also attend, as a QC project team member to provide QC guidance and oversight to such improvements.
  • Will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies.
  • Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
  • Is proficient in technical and non-technical (e.g. interpersonal) skills to ensure the continued success of the department and quality control provided to the business.
  • Creates and establishes processes and procedures to ensure compliance and adherence to regulated QC activities for cGMP operations.
  • Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of the level. Will provide input on the performance of junior team members to the department head as part of the performance management process.
  • Requirements:
  • Requires a Bachelor’s Degree in Biochemistry, Chemistry, Microbiology, Molecular and Bellular Biology, or Biology (or closely related degree with these core courses as the foundation) OR Master's degree with (4) to six (6) years of experience of PhD with one (1) to three (3) years preferred.
  • Eight (8) years of quality control experience in the pharmaceutical industry providing guidance to Manufacturing Operations, QA, and other cGMP areas.
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes.
  • Strong independent judgment and decision making abilities required.
  • Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.
  • Independent decision making capability and ability to think conceptually and understand impact of decisions critical.
  • Strong conflict resolution and negotiation skills required.
  • Proven project management skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
  • Mentoring experience required.
  • Direct experience is required in method qualification, method transfer, and method validation in accordance with ICH guidelines.
  • Possess strong conflict resolution and negotiation skills
  • Must be able to independently represent the department in a wide-assortment of situations
  • Emerging leadership and mentoring experience required. Must be able to indirectly lead others at the bench in the absence of the department head.
  • Direct experience is desired in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems.
  • Experience in method development is desired.
  • Knowledge of and the ability to implement CFR, USP, and ICH requirements is required.
  • Knowledge of LIMS and Waters Empower Chromatography Data System is desired. Ability to implement and demonstrate testing in accordance with 21CFR11 is required.
  • Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned.
  • Visual Demands - Must be able to read and see clearly.
  • Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
  • Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.

Desired Experience, Skills and Abilities:

  • Capability to establish good relationships with others who have different values, cultural styles and perspectives. Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older
  • 190998