Quality Control Analyst I

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. Learns and executes defined QC tasks efficiently and consistently. Results are compared to specifications and documented in a timely manner. Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

GENERAL RESPONSIBILITIES:

• Technical Expertise
  • Demonstrated 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.
  • Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
  • Performs Karl Fisher, pH, container closure, testing
  • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
  • Prepares and reviews Certificates of Analysis
  • Formulates and tests in process solutions to determine final product ratios
• 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 log books, 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 log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
• Problem Solving/Decision Making
  • Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. Collaborate with Supervisor to implement corrective actions in response to assay and/or instrument problems.
  • Contribute to discussions with the team to meet group goals
  • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and method performance issues. Alert Supervisor and make detailed observations in support of investigations.
• Planning
  • Plans execution of individual tests and activities in conjunction with Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (i.e. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
  • Prepare reports as directed by Supervisor. Collaborate with Supervisor to incorporate changes/revisions as necessary in order to generate a complete report that will be ready for upper management review.
• Supervision
  • Receives minimal supervision on routine assignments. Receives specific direction on new work.
  • No formal supervisory responsibility.
• 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
• General laboratory skills
• Must be detailed oriented and show proficiency in aseptic and laboratory technique
• Ability to work independently, as well as, participate on 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.

EDUCATION AND EXPERIENCE:

• A minimum B.S. degree in a relevant scientific discipline with 0-2 years relevant laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.

GENERAL JOB COMPETENCIES:

• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held.
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
• Information organized and accessible, maintains efficient work space, manages time well.
• Manages workload, works efficiently, and meets goals and objectives.
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements.
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity.

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).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, gown, and facemasks is required.

BENEFITS:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance