Senior PQA Analyst

Artech-Information-Systems-L.l.c.; Barceloneta (PR); On-site; USD 52,000 - 56,000; Full time

Job summary

JobDiva, Inc. is seeking a Senior PQA Analyst in Barceloneta, PR to oversee QA activities for TPM plants and related manufacturing processes. The role includes approving manufacturing directions, evaluating investigations, and supporting regulatory submissions with cross-functional teams.

Ideal candidates possess a BS in Engineering or Science, 5–7 years in pharmaceutical operations, and strong analytical and communication skills in English and Spanish.

Qualifications

• BS in Engineering or Science; GMP knowledge; 5-7 years pharma ops; strong analytical skills.
• Experience with GMP regulations affecting pharmaceutical products and quality systems.
• Strong communication skills across levels and teams; ability to collaborate with GMP/compliance groups.

Responsibilities

• Review and approve manufacturing directions to the production floor.
• Investigate TPM events and ensure CAPA with thorough documentation.
• Monitor process tracking, trending, and product quality performance.
• Lead annual Product Quality Review per global procedures.
• Serve as liaison with TPM sites for regulatory submissions and changes.

Skills

GMP regulations

Analytical skills

Interpersonal communications

Quality systems

Bilingual English/Spanish

Education

Bachelor's degree in Engineering or Science

Tools

SAP

LRMS

Change management

Job description

Title: Senior PQA Analyst
Location: Barceloneta, PR 00617
Duration: 12+ months
Pay Range: $38-$41.43/hr

The Senior Product Quality Assurance (PQA) Analyst has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between company regulatory areas and TPM plants for regulatory submission.

Responsibilities

• Maintains an effective liaison and cooperative relationship with other Client Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
• Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by Client QA Operations.
• Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
• Review and approve manufacturing directions to the production floor.
• Provide support to PQA in global projects and events to ensure intended results are achieved, including planning, risk analysis, and implementation.
• Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
• Perform annual Product Quality Review according to Client global procedure to comply with regulatory requirements.
• Participates in Trend Review Board to monitor process track and trending.
• Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
• Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.

Qualifications

• Bachelor’s degree preferably in Engineering or Science
• Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• Comprehensive knowledge and application of business and quality concepts
• Strong analytical skills and attention to detail
• Change plan, Exception Reports, SAP and LRMS experience is highly preferred
• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
• Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
• BS degree and/or 7 to 7 years equivalent experience
• Experience Level = 5-7 Years

What are the top 3-5 skills:

1. Bachelor’s degree preferably in Engineering or Science & Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
2. Strong analytical skills and attention to detail and, strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
3. Knowledge of GMP regulations and standards affecting pharmaceutical products
4. Comprehensive knowledge and application of business and quality concepts
5. Change plan, Exception Reports, SAP and LRMS experience is highly preferred
6. Fully Bilingual English & Spanish
7. Candidate may work independently and have experience in Quality systems.

Daily Work Schedule Expectations Monday to Friday 8-5PM

If remote opportunity exists what are the options i.e., 1 day remote, 4 days on-site

Is Travel expected? If so, will it primarily be domestic or international? Not expected.

Is the new hire going to be working with Toxins? NO

How many rounds of interviews: 2 rounds

Type of interview (video, phone or onsite): 1st interview via teams 2nd interview will be onsite