Summary:
Responsible for execution of microbiology tests to evaluate environment, utilities, raw materials, in-process and drug product in accordance with approved methodologies, procedures, and cGMP regulations.
Responsibilities:
Conducts routine and non-routine micro analyses of raw materials, in-process materials, finished goods and stability samples.
Monitors testing procedures to ensure that all tests are performed according to established specifications, standard test methods, or protocols.
Interprets test results, compare them to established specifications and control limits, and makes recommendations on appropriateness of data for material release.
Completes documentation needed to support testing procedures including data, forms and equipment logbooks.
Compiles laboratory test data and performs trend analyses as required.
Authors scientifically sound out-of-specification and non-conformance investigations and recommends corrective actions.
Ensure that laboratory safety standards are followed and maintained.
Other Duties:
Participates in internal or external assessments and audits as required.
Writes or revises micro standard operating procedures.
Education and/or Experience:
Bachelor’s degree in Microbiology or equivalent. Advanced degree desirable.
5+ years of quality control experience in a pharmaceutical or biotech environment
Expertise in organism identification.
Knowledge and understanding of cGMP regulations and good documentation and laboratory practices
Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)
Travel:
Limited travel but willing and able to travel if required, including internationally.
Core Competencies:
Technical Capability
Communication Proficiency
Interpersonal Skills
Organizational Skills
Presentation Skills
Problem Solving/Analysis
Romark Core Values
Vision - Big vision, no limits; purpose-driven; ability to identify potential problems or impediments and to see through them
Competence - Exceptional knowledge and understanding of the work we are called to do; exceptional critical thinking skills
Ingenuity - Original, creative, clever, innovative, perceptive and/or intuitive in solving problems or meeting challenges
Courage - Willingness to take calculated risks to accomplish a noble mission
Passion - Intense compelling enthusiasm or desire to achieve our calling/fulfill our purpose
Integrity - Having a clear vision and understanding of that which is right and doing it; being faithful to patients and healthcare professionals
Relationships - Trusted business partners, engaging others with professionalism, grace and respect in valued long-term relationships
Personal Responsibility - Leadership, dependability, doing our jobs and going beyond the call to ensure success of the organization
Respect -Humility; exhibiting special appreciation for medicines, for our work, for the responsibilities and opportunities with which we have been entrusted
Perseverance - "In it to win it" – steadfast despite difficulty or delay
Excellence - Being outstanding or extremely good in everything we do
Qualifications
Skills
Behaviors
:
Motivations
:
Education
Required
Bachelors or better in Microbiology.
Experience
Licenses & Certifications
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
