Sr. Microbiologist in Raleigh, NC at Apex Life Sciences

Date Posted: 6/5/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Raleigh, NC
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    6/5/2018
  • Job ID:
    855648

Job Description


Lab Support is seeking a Sr. Microbiologist for a growing pharmaceutical company in Raleigh, NC!

Job Summary:

Performs biological assays of commercial product raw materials, production in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples and components as well as some specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, company's standard operating procedures, and approved license requirements. Results are compared with specifications and documented. The candidate will work with and guide the efforts of Microbiology lab personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory documents. Candidate is responsible for maintenance and analysis of Microbiology data and works with other plant personnel to resolve problems related to actual or potential product quality concerns. Candidate has mastered most or all of fundamental technical and quality concepts and provides guidance and training to more junior staff members.

Job Responsibilities:

Leads and executes protocols (including environmental monitoring studies and equipment/method validations). Performs biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Laboratory assays included particulate testing, growth promotion of media, sterility testing, raw material testing, bioburden, membrane filtration, plate reading, endotoxin testing and environmental monitoring. Works in a team environment to support internal and external customer microbiology testing services.

Identifies basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation process to resolve and correct. Performs studies to support the validation of test methods and ongoing validation studies as needed. Ability to teach and perform gown qualifications for all personnel in the facility. Implements on-going studies to document the scientific suitability of test methodologies fundamental to conformance and assessment. Ability to carry out method development/validation work with minimal guidance.

Accountable for the accuracy and validity of testing results. Analyzes trends microbiology data on a monthly basis to identify potential concerns with product quality and correct deviant situations. Leads studies to support sterilization validation and validation of endotoxin removal. Performs mathematical calculations, interprets results, and records observations. Ability to keep accurate records and performs monthly trend analysis for microbiology data to identify potential concerns with product quality and correct deviant situations. May utilize Laboratory Information Management Systems. Develops problem solving skills. Compiles data and generates reports in support of investigations, APQRs, KPI’s, QMRs, and validations.

Trains more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor. Mentors analysts by providing technical knowledge and support in resolving technical problems and reviewing documents. Takes initiative; seeks out additional assignments, etc.

Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. Assist in coordinating the testing activities of the group. Ability to represent the microbiology department on relevant teams (Kaizen, Lean Sigma) to help improve processes throughout the facility. Assist in maintaining inventory and reconciliation of laboratory supplies and assist in protocol execution when needed. Assists in providing laboratory with an audit ready status as compared to global regulatory agencies as applicable. Records and reports results and significant observations. Performs special testing and assists in instrument and process validations. Responsible for maintaining inventory and reconciliation of laboratory supplies. Senior Microbiologist will take an active role in laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, new product introduction, records review, SOP/SM-R/specification management, and auditing.
 

Minimum Requirements:

Education required/ preferred:

Bachelor’s Degree preferably in Microbiology, Biology or similar life science

Experience:

Minimum 6 + years working in Microbiology, preferably in the pharmaceutical industry.

Preferred Skills/Qualifications:

Good interpersonal and verbal/written communication skills; able to use computer for data analysis

Skills/Competencies:

Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. Self-motivated, energetic, enthusiastic, and team oriented.

Other Skills:

Ability to train personnel on various procedures. MS Excel, PowerPoint, Access, and investigation writing.  Effective communication with both team members and other plant support groups. 

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

  • Reports to Microbiology Manager
  • Must work as a team member with other Microbiology personnel.
  • Ability to communicate with personnel from other areas of the plant in order to achieve a common goal or producing quality product.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.