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Manufacturing Operator/Sr. Assembler/Lead Assembler
Ref No.: 16-05322
Location: Menlo Park, California
Position Type:Contract
Manufacturing Operator/Lead Assembler
Menlo Park, CA

Under general supervision, performs precision assembly of ocular inserts within a team structure, in accordance with manufacturing and quality assurance procedures.  Performs various other area tasks according to training and department needs. The job is performed inside of a class 7 clean room.

  • Train to perform all assembly processes of ocular inserts according to established procedures.
  • With minimal supervision, responsible for the team's assembly of ocular inserts in order to produce quality volumes of product while adhering first and foremost, to GMP requirements required for the team/individual's job level.
  • Lead and mentor a small team of Assemblers in the areas of ocular insert defect identification and overall quality
  • Must maintain a high level of cooperation and positive interaction with team members and peers to meet desired results and to contribute beyond the assigned tasks.
  • Follows company/department policies and guidelines, including by not limited to, clean room adherence, company attendance and safety policies.
  • Records all traceability information and inventory movement transactions accurately.
  • Performs other duties as assigned.
  • Very good manual dexterity skills
  • Ability to lead a small team and apply common sense, personal integrity and understanding to carry out detailed but uninvolved written or oral instructions
  • Ability to read and comprehend safety rules, operating and maintenance instructions, procedure manuals, specifications, simple instructions, short correspondence, company policies and memos
  • Good verbal and written communication skills, ability to write simple correspondence
  • Understanding of GMP / ISO
  • Follow Environmental, Health and Safety guidelines
  • Strong desire for continuous learning
  • Willingness to be flexible and open minded to new processes or changes in direction
Desired/Preferred Qualifications
  • 5-8 years of experience in a medical or pharmaceutical manufacturing industry specifically with regulatory practices
  • Proven leadership and mentoring abilities, promoting constructive feedback , continuous learning opportunities and recognizing when appropriate
  • Previous experience within a team environment, desire for collaboration in order to problem solve and achieve business objectives
  • Basic computer skills
  • Proven ability to take initiative, model desired behaviors under minimal supervision
  • Proven ability to interface with an auditor
  • Proven ability to work with minimal supervision and to flex between tasks and product lines, when needed
Physical Job Requirements
  • While performing the duties of this job, the employee is regularly required to sit for quite a few hours at a time. 
  • Must be able to perform repetitive job tasks.
  • Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Frequent use of a microscope.
  • Exposure to chemicals.
  • Occasionally will lift 15 to 25 pounds.