Position Summary: Performs advance microbiological testing on water, bulk pharmaceutical chemicals and drug product; collects samples and prepares standard and sample solutions; maintains appropriate records; provides lead supervision and training to junior staff, and performs highly technical and specialized duties

• All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary
• Any non-essential functions are assumed to be included in other related duties or assignments
• Carries out responsibilities in accordance with the organization's policies, procedures, and state, Federal and local laws
• Responsible for creating daily schedule for the team
• Responsible for facilitating morning meetings with the team
• Responsible for writing lab investigation reports
• Performs test method suitability/method validation
• Performs equipment validation
• Performs microbial limit testing
• Performs change control for SOP revisions
• Responsible for reviewing of annual and semi-annual trending reports
• Assists group leader with metrics
• Complies with all company policies and procedures, including safety rules and regulations
• Performs related duties as assigned
• Solid understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis and other general analytical techniques
• Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data
• Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions
• Selects methods, techniques, and evaluation criteria for obtaining results
• Acts independently and proactively to recommend methods and procedures for problem resolution
• Exposure to fumes, odors, dusts, mists or gasses (for non-office)
• Exposure to moving mechanical parts or moving equipment
• Exposure to low to moderate to loud noise levels

May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses, gloves, hearing protection, etc.)

• Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered
• Requires a Bachelor's degree, preferably in Chemistry or Microbiology with a minimum of two years relevant progressive experience in a Quality Control Laboratory environment
• Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs
• Ability to effectively communicate scientific and/or technical ideas in writing
• Ability to communicate effectively with excellent written and oral communication skills
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders
• Self-directed with ability to organize and prioritize work
• Detail oriented with ability to identify errors and/or inconsistencies while performing tasks
• Sitting for extended periods of time at work station or mobile equipment
• Standing for extended periods of time at work station or equipment
• Using fingers to perform activities such as picking, pinching or typing
• Walking to move short distances quickly and frequently
• Twisting/Reaching - turning at waist and extending hands and/or arms in any direction
• Grasping - applying pressure to an object with the fingers and palm
• Repetitive Motions (frequent motions of the wrists, hands and/or fingers)
• Lifting - raising from lower to upper and/or moving objects horizontally up to 25 lbs
• Visual Acuity:

Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes

• We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays
• Life and Disability Protection: Company paid Life and Disability insurance

Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more