Quality Assurance Associate

4 days ago

Rochester, Minnesota, United States PHARMACEUTICAL SPECIALTIES, INC Full time

Available Position

Quality Assurance Associate

Provides support activities in Quality Assurance (QA), Quality Control Laboratory (QC) and Production departments, which includes manufacturing and packaging.

ESSENTIAL JOB FUNCTIONS

  • Batch record preparation
  • Author and maintain master batch records
  • Manage material and bulk product inventory
  • Review of GMP records to ensure compliance with established specifications and procedures
  • Disposition (i.e., release or reject) raw materials, bulk product, and finished product
  • Data entry, scanning, and filing documents
  • Assist with return goods handling
  • Assist with material inspection and sampling
  • Must maintain and follow current Good Manufacturing Practices (cGMP) requirements and Standard Operating Procedures (SOP)
  • Provide support for the Production Department with the above duties

COMPETENCIES

  • High degree of accuracy
  • Aptitude for science-related work, and good math and written/language skills
  • Good working computer skills; proficient knowledge of Microsoft Office
  • Good communication skills
  • Be self-motivated
  • Work well as a team member and the ability to work with multiple departments

SUPERVISORY RESPONSIBILITY

  • There are no supervisory responsibilities for this position.

WORK ENVIRONMENT

  • While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving parts and vibrations. The noise level in the work environment is usually moderate.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.

  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, use hands to handle or feel, and reach with hands or arms. The employee is occasionally required to sit, stoop, kneel, crouch or stand for periods of time. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

USUAL WORKING HOURS

  • Monday – Friday 6:30 a.m. – 3:00 p.m.
  • Capability to work a flex shift and extended hours if necessary.

TRAVEL

  • No travel expected for this position.

REQUIRED EDUCATION/EXPERIENCE

  • Bachelor of Science, or
  • Associates degree with laboratory experience, or
  • Three years of quality assurance experience

ADDITIONAL ELIGIBILITY QUALIFICATIONS

  • Language skills- must be able to read, record and speak the English language, interpret documents such as directions, instructions, safety rules, and procedure manuals in the English language. Must be able to record written information accurately.
  • Reasoning ability- must have the ability to apply good judgement and understanding to carry out instructions furnished in written, verbal or diagram form. Must be able to deal with simple problems in an organized and efficient manner.

COMPENSATION AND BENEFITS

  • This position is eligible for all full-time benefits including:
  • Health, Dental, Life, and Disability Insurance
  • HSA, HRA, and Day Care Assistance Plans
  • 401(k) Retirement Plans with Profit-Sharing
  • Bonus opportunities
  • Generous PTO and paid holidays
  • The starting wage for this position is $28.00 per hour.

EEO STATEMENT

PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice.

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