"Alerted.org

Duration: 12 months contract

**Shift:** Work Schedule (includes weekends, and possibly nights)

Once shift is determined shifts will be on a stable schedule.

Job Description:

The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance

Key Responsibilities:

+ Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

+ Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

+ Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.

+ Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.

+ Oversee and provide guidance during on-the-floor analytical testing.

+ Ensure that changes that could potentially impact product quality are assessed according to procedures.

+ Ensure that deviations from established procedures are investigated and documented per procedures.

+ Alert senior management of quality, compliance, supply and safety risks.

+ Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.

+ Identification and implementation of continuous improvement opportunities within our processes and systems.

+ Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site

Basic Qualifications:

+ High school/GED + 4 years work experience or

+ Associate + 2 years work experience or

+ Bachelor + 6 months work

Must Have Skill Sets:

+ Previous work on GNP Facilities

+ PQA or Mfg. preferably Drug Substance Experience

+ Previous work with Batch records/Deviations/Qa Oversight

+ Nice to have B.S. degree

Day to Day Responsibilities:

+ On the floor guidance/Mfg. support

+ Oversee compliance in execution

+ Batch Record Review

+ SOP review/Approvals

+ Deviation Review

+ Help Mfg. Problem solves with Quality mindset

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"