Description

Shift Scheduled: Monday to Friday 8am – 5 pm 

Core essential skill sets candidates must have to be considered for the role:

• Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience
• Microbiology, Biology, Biochemistry bachelor degree or similar science education
• Minimum of two years relevant progressive experience in a Quality Control in CGMP pharmaceutical, biotechnology or environmental laboratory
• Experience to Labware LIMS V7 and laboratory auditing processes
• Microbiology testing experience on Environmental Samples for surface and air, Purified Water Samples, and RM/FP Microbial Limit Test following USP
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS)
• Ability to communicate effectively with excellent written and oral communication skills for scientific and/or technical ideas
• Acts independently and proactively to recommend methods and procedures for problem resolution
• Self-directed with ability to organize and prioritize work
• Understand Data Integrity (ALCOA+) and laboratory documentation practices

Position Summary

• This position performs testing of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records.

Essential Areas Of Responsibility

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.
• Complies with all safety rules and regulations.
• Perform analysis on raw materials, finish goods, API, and control substances
• Ensures that balances are reviewed and calibrated.
• Perform peer review of laboratory testing as required.
• Responsible for Wet Chemistry testing (such as LOD, PH, titration, etc.)
• Work within a team to meet productions, validation, stability, and request deadlines.
• Participates in troubleshooting of analytical test methods and laboratory instruments.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions.
• Responsible for performing additional related duties as assigned.

Position Requirements

• Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Requires a Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience 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.
• Labware LIMS and/or Empower preferred experience preferred.
• Microbiology testing experience preferred.

Skills/Knowledge/Abilities:

• Solid understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis and other general analytical techniques.
• 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 the ability to identify errors and/or inconsistencies while performing tasks.
• Business, scientific and personal computer hardware and software applications.
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
• Must be able to maintain the highest levels of confidentiality, integrity and discretion.
• Excellent verbal, written, and interpersonal skills required.

Problem Solving:

• 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.
• Able to identify solutions to general problems through collaboration and creativity.

Travel Requirements N/A

Physical Requirements

Frequent:

• Sitting for extended periods at workstation or mobile equipment.
• Standing for extended periods at workstation or equipment.
• Using fingers to perform activities such as picking, pinching or typing.
• In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals.
• However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose an undue hardship on the Company.
• The requirements and responsibilities in this position description do not create an employment contract and are not meant to be all-inclusive.
• The incumbent is responsible to ensure compliance with all laws, regulations, codes, standards and company policies relevant to this position.
• This document in no way states or implies that only the duties described above are to be performed by the incumbent.
• The incumbent will be expected to follow instructions and perform duties as required by his or her supervisor and understand that aspects of their position may be changed by the Company on an as-needed basis.

Occasional:

• 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 – Rising 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, and 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.

Working environment:

• 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.).
• Fast paced environment.
• Able to manage multiple priorities and ensure appropriate follow-ups.
• Highly organized and excellent time and project management skills with the ability to juggle a wide range.
• Ability to work under pressure and meet deadlines