Performs testing, reviews test data, and writes investigations in compliance with cGMPs and SOPs.
Responsibilities :
Analyze products in compliance with cGMP regulations and SOPs.
Follow work instructions and standard operating procedures.
Inspect production areas, production processes, and finished goods produced.
Complete and maintain appropriate documentation to support testing procedures and comply with GMPs, including but not limited to data capture forms, equipment logbooks, and inventory forms.
Calibrate and maintain laboratory equipment according to maintenance schedules, GMP requirements, and SOPs.
Monitor cleanliness of production areas and report unacceptable conditions to the direct supervisor.
Read, understand, and follow SOPs; comply with current GMP requirements as mandated by the FDA.
Swab all production equipment cleaned and sanitized by sanitation staff using ATP instruments to ensure they meet pass thresholds before production use.
Prepare and drop off customer samples for shipment.
Document all retained samples pulled in an Excel workflow.
Conduct a detailed review of the BOM (Bill of Materials) and production processes before production begins.
Follow all safety regulations.
Perform other related duties as assigned by management.
Qualifications :
Education : Bachelor’s degree (B.S.) in a related field preferred or equivalent work experience.
Experience : Two to four years of related experience or equivalent.
Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product / process validation.
Ability to develop clear, concise, and timely oral and written reports.
Experience in laboratory environments, equipment operation, and safety procedures.
Experience in research and development, including an understanding of statistical analysis.
Commitment to excellence and high standards.
Excellent written and oral communication skills.
Strong organizational, problem-solving, and analytical skills.
Ability to manage priorities and workflow.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Acute attention to detail.
Demonstrated ability to plan and organize projects.
Ability to work independently and as a member of various teams and committees.
Proven ability to handle multiple projects and meet deadlines.
Ability to work on complex projects with general direction and minimal guidance.
Working knowledge of data collection, data analysis, evaluation, and the scientific method.
Competencies :
Analytical Skills : Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.
Technical Skills : Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
Customer Service : Manages difficult or emotional customer situations; responds promptly to customer needs; solicits customer feedback to improve service; meets commitments.
Interpersonal Skills : Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new approaches.
Oral Communication : Speaks clearly and persuasively in both positive and negative situations; listens and seeks clarification; demonstrates group presentation skills; participates in meetings.
Written Communication : Writes clearly and informatively; edits work for spelling and grammar; adapts writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
Teamwork : Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; supports team success.
Quality Management : Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
Physical Demands and Work Environment
Physical Requirements :
Continually required to stand.
Occasionally required to walk.
Continually required to use hand and finger dexterity.
Frequently required to climb, balance, bend, stoop, kneel, or crawl.
Continually required to talk or hear.
Continually utilize visual acuity to operate equipment, read technical information, and / or use a keyboard.
Occasionally / frequently / continually required to lift / push / carry items up to 50 pounds.
Work Environment :
Occasionally / frequently work near moving mechanical parts.
Frequently work around fumes, airborne particles, or toxic chemicals.
Warehouse environment includes both climate-controlled and non-climate-controlled areas.
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