<p>Salary Range:$60,000.00 To $80,000.00 Annually</p> <p>Summary of Primary Responsibilities:</p> <p>Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation.)</p> <p>Specific Responsibilities:</p> <ul> <li>Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples </li><li>Perform company's purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements </li><li>Complete all required documentation according to SOP </li><li>Verify work of technicians and assist in training </li><li>Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report </li><li>Provide training on environmental compliance issues </li><li>Development and validation of new or improved microbiological methods </li><li>Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports </li><li>Establishing databases for microbiological and validation data </li><li>Performs Internal Audits as scheduled </li><li>Other duties and projects as assigned </li></ul> <p>Job Complexity:</p> <p>Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and initiative within broadly defined practices and policies in selecting methods and techniques. Normally receives no instruction on routine work, general instructions on new assignments.</p> <p>Supervisory Responsibilities:</p> <p>None.</p> <p>Experience, Knowledge, and Skills:</p> <ul> <li>Requires BS in microbiology, biology or related science or equivalent experience. </li><li>1+ years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay </li><li>Experience with GMP, GLP, and FDA regulations and ISO requirements </li><li>Experience in environmental monitoring of clean room, aseptic media fill evaluation </li><li>Excellent verbal and written communication skills </li><li>Proven ability to meet deadlines for testing and reporting </li><li>Proficient in the use of Microsoft Office Suite including PowerPoint </li></ul> <p>The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.</p> <p>The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.</p> <p>submit your resume</p> <p>We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.</p>