Job Title: Senior Analyst, PQA Proposed

Job Title: Senior PQA Analyst

Purpose: Describe the primary goals, objectives or functions or outputs of this position.

• 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.
• This function also is the primary person to audit batch records for product manufactured by TPM plants and enter required ba

Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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: List required and preferred qualifications (up to 10). Include education, skills and experience.

• 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

Are you open to look at candidates willing to relocate at their own expense? NO

What are the top 3-5 skills, experience or education required for this position?

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

In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ? Candidate may work individually and with area team In cubicle

Daily Work Schedule Expectations : Monday to Friday 8-5PM

Is overtime offered or required? Candidate must be available based in business needs

Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? Candidate may work remotely some days a week Based in business needs

If remote opportunity exists what are the options (i.e., 1 day remote, 4 days on-site)? Candidate may work remotely some days a week Based in business needs

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