Investigations Specialist

KVK Tech is looking for an Investigations Writer to join our team in Newtown PA.

Primary responsibility is to investigate, document and bring to conclusion the outcome of product/processing related incidents, deviations or documentation errors reported to the site QA.

This position’s responsibilities will include, but not be limited to the following:

  • Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.
  • Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
  • Comply with FDA guidelines/Company Policies of Data Integrity.
  • Follow all DEA (Drug Enforcement Agency) regulations per laboratory SOPs.
  • Recommends, proposes, and formalizes alternatives for the improvement of processes, utilities, and systems.
  • Responsible for writing and reviewing Risk Assessment Report per Q9. Responsible for writing and reviewing Protocols and Reports.
  • Responsible for thoroughly investigating events as it relates to deviations and customer complaints communicated to or informed by QA and applying a science-based approach to accurately, correctly, and timely document the final report utilizing appropriate investigation techniques and/or tools.

Benefits Include:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays

We are looking for applicants with:

  1. Strong technical writing skills.
  2. Results oriented, self-starter and ability to question the status quo.
  3. Proven ability to work under pressure and availability to work at any time needed. 
  4. Capable of managing the stress levels and assertiveness to obtain the participation of colleagues working in assigned tasks.
  5. Effective in organizing work, working area, managing time and planning to achieve results.
  6. Self-motivated, creative and teamwork oriented.
  7. Proficient in negotiation skills and business savvy/awareness.
  8. Proficiency in handling concurrently and effectively multiple high-priority initiatives with evident sense of urgency and sound Quality minded approach.
  9. Proficient knowledge of cGMP’s and FDA regulations.
  10. Knowledge of computer systems GMP requirements for Part 11 compliance.

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.