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Qc Laboratory Supervisor Jobs

Company

Smith & Nephew
Address , Fort Worth, 76107, Tx
Employment type FULL_TIME
Salary
Expires 2023-07-21
Posted at 11 months ago
Job Description
Role Overview:
The QC Laboratory Supervisor will coach, develop, and lead the 2nd W-Sun shift QC team to ensure Smith and Nephew products are tested in accordance with established specifications and comply with applicable regulatory guidance and company policy requirements. They will collaborate with cross functional departments including supply chain, engineering, maintenance, quality assurance, and safety to achieve site goals. This position will be responsible for supervising staff, owning NC/CAPAs and OOS investigations, the review and approval of test results, and maintaining a safe cGMP environment.
Responsibilities:
  • Oversees up to 10 direct reports
  • Oversees daily laboratory functions
  • Reviews test results for conformance with specifications and effective documents
  • Performs data review
  • On time trending of data for the assigned laboratory group
  • Participates in the budget process and monitors group spending to remain on track with annual budget
  • The supervisor of the QC Laboratory group leads and manages the day-to-day activities of the group
  • Plans work for the group to respond to changing priorities
  • Evaluates data to detect product or method-related trends
  • Leads the implementation and sustainment of lean and continuous improvement initiatives
  • Takes initiative to make things better for the company, leads by example and builds collaborative relationships
  • Writes periodic trend summaries
  • Builds a strong, responsive team that is reliable and flexible to shifting demands
  • Maintains a safe, organized and compliant work area according to company safety standards, cGMP regulations and data integrity requirements
  • Ensures communication of critical information to senior management for key decision-making
  • Compiles and analyzes data, prepares graphs and writes SOPs/reports
  • The group's responsibilities include performing routine microbial identifications (gram stain, MicroSeq), environmental monitoring, media qualifications to support routine microbiological testing in all micro labs, conducting bioburden of products, purified water TOC and conductivity testing, maintaining all documentation and equipment associated with testing.
  • Ensures ongoing compliance with major pharmacopoeia relevant to the lab
  • Coordinates and ensures compliance with cGMP and approved laboratory procedures through training of microbiologists, hands on review of effectiveness, review of documentation and initiation of preventative/corrective actions
  • Conducts document reviews
  • Ensures lab work complies with cGMP and data integrity requirements
  • Identifies discrepancies and conducts laboratory investigations in a timely manner
  • Schedules workload and ensures timely execution
  • Works independently and communicates with his/her staff
Personnel Management and Development
  • Participates in and supervises the training of QC personnel, including mentoring personnel and provides technical expertise
  • Interacts with auditors, responds to observations and recommends corrective action
  • Plans and organizes analytical projects required to achieve group and corporate objectives
  • Participates in internal and external audits
  • Sets group objectives with management
  • Provides assistance to coworkers for troubleshooting, laboratory investigations and problem resolution
  • Interviews, hires and supervises QC personnel
  • Evaluates, coaches and manages personnel performance
  • Implements process improvements with management
  • Prepares performance reviews, facilitates disciplinary actions, and resolves personnel issues
Location:
Fort Worth, TX - Vickery
Days/Shift:
Wednesday - Sunday - 2pm - 10:30pm
Education:
  • Bachelor's degree (B.S.) or equivalent from four-year college in microbiology, biology or related field required
Experience:
  • Proven competence in area to be supervised with minimum of 3-5 years of related technical experience preferred
  • Minimum of 5 years quality-related experience in a manufacturing environment or equivalent combination of education and experience preferred
  • Minimum of 1- 2 years supervisory experience in a GMP environment required
Competencies:
  • Competent with computerized data storage systems (i.e., MasterControl, MoDA, LIMS, SmartSolve, etc)
  • Excellent working knowledge of cGMP regulations for QC laboratory applications
  • Excellent teamwork and communication skills
  • Proactive and timely resolution of issues
  • Good working knowledge of compendial requirements
  • Continuous improvement mindset
  • Attentive to detail
  • Good project management and organization skills
  • Excellent working knowledge of data integrity
  • Good computer skills
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.