Sterile Manufacturing Technician

POSITION DESCRIPTION
Role / Position Title - Sterile Manufacturing Technician
Department/Function - Operations
Country - USA
Region / City (within Country) - Monroe, NC
FLSA (Exempt/Non-Exempt) - Non-Exempt
Hours - 7:00 AM - 3:30 PM, 5 days per week

POSITION SUMMARY
Glenmark Pharmaceuticals is looking for a Sterile Manufacturing Technician to join the growing team at the Monroe, NC manufacturing site. The incumbent will be responsible for the manufacturing of sterile liquids for commercial distribution and clinical trials. Personnel in this position will operate manufacturing processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.

OVERALL JOB RESPONSIBILITIES
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Follow written procedures.
• Provide assistance to other operators.
• Clearly and accurately document activities.
• Perform basic math calculations.
• Perform in-process weight checks and component counting.
• Submit in-process samples to the analytical and microbiology labs.
• Perform cleaning of rooms, tools and equipment.
• Performs specific visual inspections based on clearly outlined checks and specifications for the finished product.
• Responsible to ensure that the product meets specifications.
• Attain and maintain Aseptic Gown Certification.
• Collect samples from controlled areas and systems such as compressed gases and water.
• Operate appropriate monitoring sampling and testing equipment
• Prepare supplies required for collecting and testing of samples.
• Write clear concise observational memo and assist in investigation of controlled areas.
• Operate Autoclave to prepare/sterilize supplies as needed.
• Read, understand and review SOP’s and Protocols as require
• Review environmental data; verify all monitoring plates are received from controlled areas prior to incubation of monitoring plate into appropriate incubators.
• Enter or verify environmental data into database.

KNOWLEDGE, SKILLS AND ABILITIES
Education

• High School Diploma/GED required; Associate Degree preferred

Experience

• 2 years of experience in cGMP/Aseptic Operations Background required; 3 -5 years of experience, preferred
• FDA/cGMP/Kaizen

Physical demands and abilities

• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

ABOUT GLENMARK
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.
BENEFIT HIGHLIGHTS

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Corporate Discount Program
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Commuter Accounts
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Auto & Home Insurance
• Pet Insurance and so much more!

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.
Glenmark Pharmaceuticals Inc USA is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Type: Full-time