PURPOSE:
Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst is technically independent and has mastered fundamental quality control concepts as well as some specialized technologies. Independently coordinates activities with others both inside QC and outside the department and carries out projects with minimal supervision. Displays initiative and technical commitment and independence for study design. Organizes and provides written and/or oral presentations of work with minimal input from Supervisor. Displays ability to perform more complex studies and to make independent contributions to the development of new technologies. Provides guidance and training to other staff members.
GENERAL RESPONSIBILITIES:
- Technical Expertise
- Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
- Test methods may include (but are not limited to):
- Environmental Monitoring
- Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
- Perform Growth Promotion testing of microbiological media
- Perform Plate reading, streaking, gram staining, and microbial ID
- Perform Sterility Testing
- Product Release and Stability Testing
- Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP’s
- Perform complex testing in accordance with written protocols
- Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
- Performs Karl Fisher titration for moisture
- Performs pH determination
- Performs container closure testing
- Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
- Prepares and reviews Certificates of Analysis
- Formulates and tests feasibilities for final product ratios
- Raw Materials
- Receiving Inspection of Raw Materials
- Testing of Raw materials
- Data Analysis
- Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete.
- General Lab Support
- Test sample management and handling, maintenance of lab equipment and logbooks, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
- Participate in safety, customer, and quality audits including answering questions during tours
- Maintain and review logbooks related to equipment and inventory, may assist in ordering materials, reagents and supplies
- May be responsible for coordination of intra and/or interdepartmental activities
- Participate in safety, customer, and quality audits including answering questions during tours and providing written responses to audit findings as assigned
- Preparation of glassware for Laboratory use.
- Managing/Handling Hazardous Waste
- Problem Solving/ Decision Making
- Technically independent and contributes substantially to the interpretation of results and design of follow up studies. Propose next steps to Supervisor for approval prior to execution. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation
- Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals
- Independently communicates interdepartmentally and with outside contacts to solve technical issues and communicates results to the Supervisor.
- Propose to Supervisor investigative and troubleshooting of Quality Control Methods and SOP’s to improve compliance, efficiency and/or reduce cost (e.g. recommend purchase of new equipment or instrument to upgrade or replace obsolete model, identify new alternative methodology/technologies, performing gap analysis to ensure alignment with cGMP or regulatory guidance’s) . Present idea to Supervisor for approval
- Utilize colleagues and literature to solve complex problems
- Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations
- Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed
- Represent QC at cross functional meetings as assigned in a leadership capacity (this includes disseminating information in a professional manner with the groups goals represented)
- Planning
- Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
- Prepare reports independently and submit them to the Supervisor for approval. Reports should be ready for upper management review at time of submission to Supervisor
- Prepare metrics reports including statistical analysis of results when required
- Prepare training plans when required
- Supervision
- Receives overall direction from Supervisor and carries out test without supervision.
- May supervise junior staff members
- Provides training of other staff members
- Perform other additional job-related duties as required
Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Organizational skills
- Time management skills
- General laboratory skills
- Must be detailed oriented and show proficiency in aseptic and laboratory technique
- Ability to work independently, as well as participate in teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
- Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
- Required to pass a pipetting proficiency training and certification course
- Required to pass LAL Training and Certification
EDUCATION AND EXPERIENCE:
- A minimum of a B.S. degree in a relevant scientific discipline or equivalent or a combination of experience and education required w/ 4-6+ years of laboratory experience within a cGMP regulated environment.
M.S. degree in a relevant scientific discipline preferred w/ 4+ years of laboratory experience within a cGMP regulated environment.
GENERAL JOB COMPETENCIES:
- Create and edit documents utilizing Word, Excel, PowerPoint and LIMS.
- Meet deadlines, work independently, accountable, maintain focus, punctual, good attendance record
- Information is organized and accessible, maintains efficient workspace, manages time well.
- Manage workload, work efficiently, and meet goals and objectives
- Strive to eliminate errors, accurate work is a priority, compliant with quality system requirements.
- Maintain current understanding of technical processes/equipment.
PHYSICAL REQUIREMENTS:
Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand). The ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gowns, and facemasks is required.
SALARY:
$56,000-$79,000 a year
PAY RANGE DETAILS
The pay range listed on each job posting at acc represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.
