Qc Laboratory Supervisor Jobs

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:

• Conducts document reviews
• 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
• On time trending of data for the assigned laboratory group
• Performs data review
• Maintains a safe, organized and compliant work area according to company safety standards, cGMP regulations and data integrity requirements
• Ensures ongoing compliance with major pharmacopoeia relevant to the lab
• Writes periodic trend summaries
• 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.
• Oversees up to 10 direct reports
• 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
• Identifies discrepancies and conducts laboratory investigations in a timely manner
• Reviews test results for conformance with specifications and effective documents
• Builds a strong, responsive team that is reliable and flexible to shifting demands
• Participates in the budget process and monitors group spending to remain on track with annual budget
• Ensures communication of critical information to senior management for key decision-making
• Schedules workload and ensures timely execution
• Evaluates data to detect product or method-related trends
• Works independently and communicates with his/her staff
• Compiles and analyzes data, prepares graphs and writes SOPs/reports
• Plans work for the group to respond to changing priorities
• The supervisor of the QC Laboratory group leads and manages the day-to-day activities of the group
• Oversees daily laboratory functions
• Ensures lab work complies with cGMP and data integrity requirements

Personnel Management and Development

• Prepares performance reviews, facilitates disciplinary actions, and resolves personnel issues
• Implements process improvements with management
• Participates in internal and external audits
• Participates in and supervises the training of QC personnel, including mentoring personnel and provides technical expertise
• Sets group objectives with management
• Interviews, hires and supervises QC personnel
• Evaluates, coaches and manages personnel performance
• Interacts with auditors, responds to observations and recommends corrective action
• Provides assistance to coworkers for troubleshooting, laboratory investigations and problem resolution
• Plans and organizes analytical projects required to achieve group and corporate objectives

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:

• Good computer skills
• Good working knowledge of compendial requirements
• Attentive to detail
• Continuous improvement mindset
• Proactive and timely resolution of issues
• Excellent teamwork and communication skills
• Excellent working knowledge of cGMP regulations for QC laboratory applications
• Good project management and organization skills
• Excellent working knowledge of data integrity
• Competent with computerized data storage systems (i.e., MasterControl, MoDA, LIMS, SmartSolve, etc)

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.