What are the responsibilities and job description for the Quality Control Analyst II position at Associates of Cape Cod Inc?
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 has mastered most or all of the fundamental quality control concepts as well as some specialized technologies and receives minimal supervision on routine assignments. Analyzes and interprets test results independently and contributes to design of new studies in consultation with Supervisor. May provide guidance and training to more junior 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
- Proficiency is defined in the individual performance objectives,
- 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 testing of samples with increasing complexity 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 in process solutions to determine final product ratios
- Environmental Monitoring
- 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
- Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
- Problem Solving/Decision Making
- Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. 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
- Communicates interdepartmentally and with outside contacts to solve technical issues as directed by Supervisor
- When conducting testing, if SOP’s or test methods (e.g. Method of measuring pH) are not optimal, propose ideas for development and optimization in order improve compliance, efficiency and/or reduce cost (e.g. Align current procedures with current practices, consolidate forms or procedures, recommend purchase of new equipment or instrument to upgrade or replace obsolete model). Present idea to Supervisor for approval.
- Begins to 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.
- 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 to Supervisor for review. 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 overall direction from Supervisor and carries out test without supervision.
- No formal supervisory responsibility
- May provide training to 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
- 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 of a B.S. degree in a relevant scientific discipline w/ 2-4 years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.
M.S. degree preferred in a relevant scientific discipline w/ 0-2 years of laboratory experience within a cGMP regulated environment.
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
- Referral program
- Tuition reimbursement
- Vision insurance