QA Associate 1

Durham, North Carolina, United States Full-time

Position Title: Quality Associate I
Job Location(s): Durham, NC
Start Date: ASAP
Employment Type: Full-Time
Starting Salary Range: Competitive
Job Requisition #: 18068

Avista Pharma Solutions is a contract testing, development and manufacturing organization (CDMO) encompassing over 200,000 square feet of laboratory and manufacturing space across three locations (Agawam, MA – Durham, NC – Longmont, CO), providing pharmaceutical, animal health and medical device clients with a broad suite of scientifically-differentiated services.

 DUTIES:

  • Organize and inventory records in a manner that provides efficient and effective viewing and retrieval including but not limited to: testing records, training records, and equipment records.
  • Provides general office support including but not limited to: scanning records, sending records to clients, filing hard copy records, reconciling records, retrieving records and archiving records.
  • Assigns controlled document numbers
  • Works with Quality team to track trending data.
  • Updates and maintains GxP documentation in applicable software
  • Manage the logbook request forms
  • Bind approved logbooks and distribute as needed
  • Support Quality project initiatives
  • May be asked to perform additional duties in assigned and unassigned areas.

QUALIFICATIONS:

  • High school diploma or equivalent with 1+ years of office experience and/or regulated work experience.
  • Basic understanding cGMP requirements for role
  • Good computer skills, including Microsoft Word, Excel, and Outlook, and Internet.
  • Understands the importance of following all company SOPs
  • Basic office and organizational skills, filing, setup up and maintain systems to support the organization
  • Knowledge of business English, correspondence formats, spelling and grammar sufficient to proofread materials and ensure the accuracy and completeness of written communications.

SUCCESS FACTORS:

  • Detail-oriented, organized and applies effective time management skills in order to meet all deadlines. Able to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
  • Promotes a safe work environment.
  • Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers.
  • Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures.
  • Effectively communicates both verbally and in writing.
  • Ability to read and comprehend detailed written instructions.
  • Ability to clearly and concisely document all work activities in a timely manner utilizing existing forms and records. Writes legibly.
  • Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills.
  • Must have the ability to work overtime when required.
  • Must adhere to attendance policy of Avista. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time.
  • Ability to work effectively within a team environment.

Avista Pharma Solutions is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.