Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
Position Summary
The Sr. Quality Control Analyst is accountable for driving results in a fast-paced environment by performing complex microbial analysis and assisting with method development and validation. The Assistant Scientist II may assist in GMP review, provide problem-solving support and Laboratory Investigation Report ownership for the Microbiology Department. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Essential Functions
Maintains working knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.
Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor's instructions.
Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature and nutrition.
Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination.
Examines physiological, morphological and cultural characteristics, using a microscope and other relevant equipment, to identify and classify microorganisms in test articles.
Studies impact of microorganisms on products and evaluates the impact of microbial control strategies on microorganism survival.
Prepares technical write up and assists in report generation.
Accurately completes GMP reviews as assigned.
Maintains lab stock of microbial cultures.
Interacts with clients.
Trains others on individual core technologies.
Reviews and revises procedures as requested and performance of advanced methods.
Participates in company training and maintains the current status of certifications.
Complies with applicable GMPs.
Provides technical training and leadership for subordinate technical positions.
Maintains a safe, clean and organized work environment free from safety hazards.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
Bachelor's Degree in Chemistry, Biology or Microbiology with 3 - 5+ years of related experience.
Course work in Microbiology expected.
Alcami Non-Negotiables
Consistently demonstrates honesty and integrity through personal example.
Follows all safety policies and leads by example a safety first culture.
Produces high quality work product with a focus on first time right.
Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
Functional Competencies
Knowledge of Chemistry and Biology plus course work in Microbiology.
Basic and moderately complex mathematical functions.
Familiar with GMP regulations.
General working knowledge of Microsoft Office applications.
SAP project status and CATS time entry functions.
Moderate familiarity with classes of organisms.
Basic knowledge of microbial taxonomy procedures.
In-depth understanding of microbiology test procedures including: preservative effectiveness, sterility testing, bacterial endotoxins, microbial limits, antimicrobial effectiveness, compendial regulation/methods.
Understanding of basic theory of Microbiology test procedures and validation.
Understanding of methods for environmental monitoring.
Good documentation practices.
Able to execute procedures as written.
Ability to recognize deviations from procedures and need for investigations.
Good aseptic techniques.
Able to independently use more complex lab equipment.
Ability to independently perform routine microbiological test procedures.
Able to perform more complex methods with supervision.
Perform method development and validation studies with supervision.
Assist in investigations.
Able to train less experienced analysts.
Ability to perform environmental monitoring.
Decision Making and Supervision Required
Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
Receives minimal instruction on day-to-day work, general instructions on new assignments.
Travel Requirements
Up to 5% travel required.
What We Offer You:
* Competitive salary with career advancement opportunities
* Bonus plan
* Medical, dental and vision coverage from day one
* 401(k) with company match
* Company paid vacation, holiday and sick-leave
* Voluntary benefits including short & long-term disability, life, accident, critical illness insurances
Diversity and Inclusion:
Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
